[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"InSightec\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":250},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,40,67,92,118,130,155,172,199,226],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100053619","embrace-tremor-bifus-100053619",false,"NCT06974916","EMBRACE Tremor BiFUS","International, Multicenter, Investigator Blinded, Randomized And Controlled Essential Tremor Trial With Staged-Bilateral FUS","Inclusion Criteria:\n\n1. Men and women with an age of 18 years or older (according to local labeling).\n2. Willing to participate in the study (i.e., signed ICF). (Willing to be randomized).\n3. Patient is able to undergo a high-resolution Computerized Tomography (CT) scan.\n4. Patient is able to fit into MRI unit and comply with all contraindications for the specific magnetic resonance (MR) system including and limited to contrast medium should there be needed.\n5. The thalamus, sub-thalamus and the pallidum must be apparent on MR imaging.\n6. Patient is able to communicate sensations to the physician during the procedure; Procedure does not require general anesthesia.\n7. Patient must be able to use the Stop Sonication button freely.\n8. Patient willing to have their head shaved prior to the actual treatment.\n9. Patient has no history for claustrophobia which is not responding to medications.\n10. ET patients who are eligible for second side staged bilateral Exablate thalamotomy treatment (according to local labeling). Time since first intervention is at least 9 months.\n11. Available tremor assessment prior to the unilateral Exablate thalamotomy.\n12. Patients randomized to the study, irrespective of group allocation should be willing and able to remain in the study for at least 6 months and able to complete the required assessments.\n\nExclusion Criteria:\n\n1. Subject experienced any non-transient neurological event or worsening following the previous Exablate procedure.\n2. Patients with MRI related contraindications (e.g. presence of metallic implants incompatibility with MRI, severe claustrophobia, reaction to contrast medium).\n3. Patients in whom it is not possible to avoid energy absorbing structures or sensitive tissues (e.g., skull implants, surgical clips, shunts, electrodes, dura patch, skull patch, electrodes, etc.) from the path of the ultrasound beam.\n4. Patients with concurrent active infections disease and\u002For severe allergies with fever.\n5. Patients that have been diagnosed with brain tumors or a vascular anomaly.\n6. Patients with a history of seizures, brain hemorrhages, stroke within the past year, or any coagulopathy.\n7. Patients under anticoagulants and\u002For anti-platelets drugs known to increase bleeding risk within the duration defined by the half-life of the specific drugs.\n8. Patient that has been given any contrast agent (e.g., CT, MRI), within 24 hours before treatment\n9. Severe unstable hypertension that cannot be controlled by medications (diastolic Blood Pressure \\> 100 on medication).\n10. Patients with unstable cardiac status.\n11. Patients exhibiting any behavior(s) consistent with ethanol or substance abuse.\n12. Cerebrovascular disease (multiple CVA or CVA within 6 months).\n13. Patients with risk factors for intraoperative or postoperative bleeding.\n14. Imaging shows abnormal finding in CT or\u002Fand MRI (e.g., brain tumor, brain vascular malformation, shunt, etc.).\n15. Patient has physical subscale score ≥ 16.5 on the Dysphagia Handicap Index or has been diagnosed with dysphagia.\n16. Patient with cognitive impairment.\n17. Patient with clinically significant abnormal speech function as determined by a speech pathologist.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a post-market (Phase IV) randomized, controlled, blinded, multicenter study with the aim to determine the added value of staged bilateral Exablate thalamotomy compared to a group of patients on previous unilateral treatment combined with local standard medical treatment.",[26],"Essential Tremor","RECRUITING","2026-07-09",{"date":30,"type":31},"2026-07-13","ACTUAL",{"date":33,"type":31},"2025-04-22",{"date":35,"type":20},"2028-03",{"name":37,"class":38},"InSightec","INDUSTRY",13,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100287941","a-feasibility-safety-study-of-benign-centrally-located-intracranial-tumors-in-pediatric-and-young-adult-subjects-100287941","NCT03028246","A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects","A Feasibility Safety Study Using the ExAblate 4000 System in the Management of Benign Centrally-Located Intracranial Tumors Which Require Clinical Intervention in Pediatric and Young Adult Subjects","Inclusion Criteria:\n\n* Subjects with benign (WHO grade I) centrally located intracranial tumors which require clinical intervention and are known to carry minimal hemorrhage risk\n* Minimum head circumference will be 49cm\n* Skull Density Ratio (SDR) should be ≥0.35\n* Subjects should be on a stable dose of all condition-related medications for 30 days prior to study entry as determine by medical records\n* Subjects and\u002For parent(s)\u002Flegal representative can provide accurate seizure diary log for the 30 days prior to FUS treatment and for the duration of the study\n\nExclusion Criteria:\n\n* Subjects with unstable cardiac status that would increase anesthetic risk including\n* Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV\n* Subjects who are taking human growth hormone (hGH), also known as somatotropin\n* Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including vagus nerve stimulator, responsive neurostimulator, cardiac pacemakers, non-metallic shunts, size limitations, etc.\n* Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) or sedative medications\n* Severely impaired renal function (estimated glomerular filtration rate \\\u003C70% of normal GFR for age) or receiving dialysis\n* Any history of clinically significant abnormal bleeding and\u002For coagulopathy\n* Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin, NSAIDs) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure; or, unable or unwilling to stop anticoagulant for the purpose of focused ultrasound procedure\n* Use of valproate derivatives for seizure control within the preceding 2 weeks\n* Known or suspected acute, active, or uncontrolled infection\n* History of postnatal stroke or intracranial hemorrhage within 6 months\n* Clinical suspicion of increased intracranial pressure (as evidenced by symptoms of obstruction: headache, nausea, vomiting, lethargy, and papilledema)\n* Have participated in another interventional trial in the last 30 days\n* History of immunocompromise, including subject who is HIV positive with incomplete viral suppression\n* Known life-threatening systemic disease\n* Subjects with suicidal ideation or previous suicide attempt within the past year\n* Subjects with malignant brain tumors, or the presence of any ambiguous clinical features that could imply a malignant potential to the tumor, or for which a biopsy is necessary\n* Subjects for whom histopathology is important for ongoing management\n* Female subjects who are pregnant, breast feeding or planning to become pregnant during the study or are unwilling to practice birth control during participation in the study, if of child-bearing age","5 Years","22 Years",{"count":50,"type":20},20,[23],"The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial tumors which require clinical intervention in pediatric and young adult subjects.\n\nIndication of Use: Ablation of benign intracranial tumors in children and young adults which are ExAblate accessible.",[54],"Benign Centrally-Located Intracranial Tumors",[56,57],"Hamartoma","Hypothalamic Hamartoma","2026-06-25",{"date":60,"type":31},"2026-06-29",{"date":62,"type":31},"2017-02-28",{"date":64,"type":20},"2026-12-31",{"name":37,"class":38},3,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100377698","exablate-for-lifu-neuromodulation-in-patients-with-opioid-use-disorder-oud-andor-other-substance-use-disorders-suds-100377698","NCT04197921","Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and\u002For Other Substance Use Disorders (SUDs)","A Feasibility Clinical Trial of Exablate for Low Intensity Focused Ultrasound Neuromodulation in Patients With Opioid Use Disorder (OUD) and\u002For Other Substance Abuse Disorders (SUDs)","Inclusion Criteria:\n\n1. Males and non-pregnant females, age 18 - 60 years old\n2. Subject meets DSM-5 criteria for OUD and\u002For other SUDs including alcohol (assessed via the SCID-5) of at least two years duration\n3. Subject is currently receiving outpatient treatment from the WVU Comprehensive Opioid Addiction Treatment Program (COAT), Intensive Outpatient Program (IOP) or any other program which implements the COAT model; residential or inpatient treatment from the WVU Center for Hope and Healing or an affiliated WVU hospital; or receiving outpatient\u002Finpatient\u002Fresidential treatment from similar programs that are well known to the research team. If the subject is prescribed medication for AUD or OUD (e.g. buprenorphine-naloxone, naltrexone), they will be on a stable dose of the medication for the 7 days prior to the procedure. Stable is defined as within the therapeutic range but does not require same exact dose for 7 days.\n4. Subject has been off opioids and other illicit substances, except for cannabis, confirmed via urine toxicology screen\n5. The NAc is apparent on MRI such that treatment targeting can be performed directly (visible on MRI) and indirectly (using other anatomical structures for measurements)\n6. Subject is able to communicate sensations during the Exablate Transcranial procedure\n7. Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits\n8. Subject is able to make own medical decisions as determined by the clinical team\n9. Subject has signed and received a copy of the approved informed consent form\n\nExclusion Criteria:\n\n1. Subjects who are taking medications which may adversely interact with MOUD (See Appendix B for full list). Being on one of these medications would not automatically exclude a participant from study participation, does not automatically exclude a prospective subject from study participation. If a prospective or current subject is taking any medication listed in Appendix B, the study investigator is responsible for determining whether the subject is eligible for inclusion or continued study participation.\"\n2. Subject with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices\n3. Subject with known intolerance or allergies to the MRI contrast agent gadolinium (GADOVIST®)\n4. Subject who are unable or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours)\n5. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp\n6. Subject with implanted objects in the skull or the brain\n7. Subject diagnosed with advanced kidney disease or on dialysis\n8. Subject with impaired renal function with estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m2\n9. Subject with known unstable cardiac status or severe hypertension including:\n\n   1. Documented myocardial infarction within six months of enrollment\n   2. Unstable angina on medication\n   3. Unstable or worsening congestive heart failure\n   4. Left ventricular ejection fraction below the lower limit of normal\n   5. History of a hemodynamically unstable cardiac arrhythmia\n   6. Cardiac pacemaker\n   7. Severe hypertension (diastolic BP \\> 100 on medication)\n10. Subject with history of abnormal bleeding, hemorrhage, or coagulopathy\n11. Subject receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure\n12. Abnormal coagulation profile (PLT \\\u003C 100,000\u002Fμl), PT (\\>13.9 sec) or PTT (\\>37.5 sec), and INR \\> 1.2. If values are outside the range of normal limits, any clinically significant value may be excluded as determined by a study investigator.\n13. Subject with cerebrovascular disease as determined by MRI according to the Fazekas criteria. Grades II and III on the Fazekas scale should be excluded\n14. Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced (assessed via SCID-5)\n15. Score of greater than 17 on the Hamilton Depression Rating Scale (HAM-D) or increased risk of suicide based on any positive response regarding passive or active suicidal ideation with or without intent over the past 3 months or lifetime history of active suicidal ideation with intent on the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline\n16. History of suicide attempt\n17. Parental history of completed suicide\n18. Subject meet the criteria for Cluster A or B Personality Disorders (assessed via SCID-5-PD)\n19. Diagnosis of dementia or any other disorder which has led to a clinically significant cognitive impairment (assessed via NIHTB-CB)\n20. Subject with brain tumors\n21. Subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area\n22. Any known CNS infection or infection with the Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV). A diagnosis of Hepatitis C (HCV) alone is not exclusionary as long as hepatic function laboratory values are deemed not clinically significant by a study investigator and are ≤ 1.5 times the upper limit of normal.\n23. Subject who has had deep brain stimulation or a prior stereotactic ablation of the NAc, basal ganglia or thalamus\n24. Subject who has been administered botulinum toxins into the arm, neck, or face for 5 months prior to baseline\n25. Subject who is currently participating in another clinical investigation with an active treatment arm\n26. Subject unwilling to abstain from illicit substance use during the course of the study\n27. Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator\n28. Subject is non-English speaking\n29. Subject is pregnant or planning to be pregnant",true,"60 Years",{"count":77,"type":20},29,[23],"The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0\u002F2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) and\u002For other Substance Use Disorders (SUDs) by assessing its safety and tolerability in subjects with OUD.",[81,82],"Opioid-use Disorder","Substance Use Disorders","2026-06-24",{"date":85,"type":31},"2026-06-26",{"date":87,"type":31},"2019-11-27",{"date":89,"type":20},"2027-12-31",{"name":37,"class":38},4,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"100463681","phase-3-blood-brain-barrier-bbb-opening-using-exablate-focused-ultrasound-with-standard-of-care-treatment-of-nsclc-brain-mets-100463681","NCT05317858","Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets","A Randomized Pivotal Study Assessing the Safety and Efficacy of Targeted Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin","LIMITLESS","Inclusion Criteria:\n\n* Participant is ≥ 18 years of age\n* The participant provides written informed consent for the trial\n* Participant is willing to comply with all study procedures for the duration of the study\n* Participant has a Karnofsky Performance Status ≥ 70% and\u002For ECOG 0-2\n* Participant is a NSCLC subject prescribed immune checkpoint inhibitor systemic therapy according to on-label use with the target brain lesion(s) measuring ≥ 0.5 cm in longest diameter. Target mets may include: De novo mets for which surgery and radiation can be deferred, Mets with or without history of prior radiation, Mets with history of radiation after at least 8 weeks since last radiation treatment, and In the event a previously treated met has progressed according to institutional practice within 4 weeks post radiation treatment, the met may be study eligible, and\u002For if in the opinion of the Investigator, the subject may benefit from the study procedure.\n* Female subject is not planning pregnancy during the study duration and confirmed NOT PREGNANT each procedure day.\n* Screening\u002FBaseline laboratory values Screening\u002FBaseline should adhere to local standard of care lab values for ICI therapy\n\nExclusion Criteria\n\n* Participant has evidence of acute intracranial hemorrhage\n* Participant at risk for spontaneous intracranial hemorrhage (e.g., history of metastatic melanoma or other tissue histology).\n* Participant has signs and symptoms of increased intracranial pressure or symptomatic mass effect, midline shift or evidence of subfalcine, uncal or tonsillar herniation.\n* Participant receiving Bevacizumab (Avastin) therapy, or other drugs with a proclivity for causing bleeding.\n* History of bleeding disorders or tissue pathologies which increase the subject's risk of hemorrhage for anticoagulation medications, implement pre-surgical standard procedure to avoid increased risk of a bleeding event.\n* Participant has an infectious viral infection such as active Hepatitis B, Hepatitis C or detectable HIV viral load or participants with active bacterial infection such as TB (Bacillus tuberculosis) that may, in the opinion of the investigator, interfere with the subject receiving the study therapy or procedures or otherwise impact their participation in the trial.\n* Subjects with evidence of cranial or systemic infection.\n* Participant has received a solid organ or hematopoietic stem cell transplant.\n* Participant has received a live vaccine within 28 days prior to the first on-study ICI infusion with or without Exablate.\n* Known sensitivity to DEFINITY® ultrasound contrast agent or hypersensitivity to perflutren microsphere or its components, e.g., polyethylene glycol, as found in MiraLAX and bowel prep products.\n* Contraindications to MRI and gadolinium-DTPA including non-MRI-compatible implanted devices, severe claustrophobia, unable to lie supine in MRI.\n* Subjects with significant liver dysfunction, (cirrhosis, hemochromatosis, severe alcohol abuse, or active hepatitis (autoimmune or infectious))\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first on-study ICI infusion with or without Exablate. Note: prophylactic steroid use for ICI and chemotherapy infusion per institutional practice is allowed per protocol.\n* Has a known additional malignancy that requires active treatment that would interfere with study procedures.\n* Known presence of leptomeningeal disease.\n* Has a diagnosis of active autoimmune disease (e.g., autoimmune Hepatitis, Guillain-Barre Syndrome, etc.) requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. History of (non-infectious) pneumonitis that requires steroids or has current pneumonitis\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Subject is currently enrolled in another intervention based clinical trial","100 Years",{"count":102,"type":20},30,[104],"PHASE3","The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0\u002F2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors.",[107,108],"Brain Tumor","Non Small Cell Lung Cancer","2026-06-16",{"date":111,"type":31},"2026-06-18",{"date":113,"type":31},"2022-08-12",{"date":115,"type":20},"2027-12-01",{"name":37,"class":38},11,{"id":119,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":24,"conditions":122,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":127,"leadSponsor":128,"locationsCount":129},"100591014",{"count":19,"type":20},[23],[26],"2026-06-08",{"date":125,"type":31},"2026-06-09",{"date":33,"type":31},{"date":35,"type":20},{"name":37,"class":38},8,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":47,"studyType":140,"phases":4,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},"100480685","a-post-approval-registry-for-exablate-4000-type-10-and-type-11-for-unilateral-pallidotomy-for-the-treatment-of-advanced-idiopathic-parkinsons-disease-with-medication-refractory-moderate-to-severe-motor-complications-100480685","NCT05539196","A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications","Inclusion Criteria:\n\n* Men and women, age 30 years and older.\n* Subject undergoing a planned an Exablate procedure for their Parkinson's Disease with Motor Complications per local institution standard of care.\n* Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all Registry visits.\n* Subject has signed and received a copy of the approved informed consent form.\n\nExclusion Criteria:\n\n* Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.","30 Years","99 Years",{"count":139,"type":20},60,"OBSERVATIONAL","This registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years. The proposed registry will enroll 60 subjects and will be conducted at approximately 10 centers worldwide.",[143,144,145],"Movement Disorders","Neurology","Parkinsons Disease","2026-03-18",{"date":148,"type":31},"2026-03-20",{"date":150,"type":31},"2023-01-23",{"date":152,"type":20},"2029-07-31",{"name":37,"class":38},5,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":136,"maxAge":137,"enrollmentInfo":161,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":129},"100438634","a-post-approval-registry-for-exablate-4000-type-10-and-type-11-for-unilateral-thalamotomy-for-the-treatment-of-medication-refractory-tremor-dominant-idiopathic-parkinsons-disease-100438634","NCT04991831","A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease","Inclusion Criteria:\n\n1. Men and women, age 30 years and older\n2. Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care.\n3. Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits\n4. Subject has signed and received a copy of the approved informed consent form\n\nExclusion Criteria:\n\nSubject does not agree to participate or is unlikely to participate for the entirety of the study.",{"count":162,"type":20},50,"The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.",[165],"Tremor Associated With Tremor Dominant Parkinson's Disease",{"date":148,"type":31},{"date":168,"type":31},"2022-04-28",{"date":170,"type":20},"2027-12",{"name":37,"class":38},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":184,"conditions":185,"keywords":186,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},"100482700","mr-guided-focused-ultrasound-plus-gcase-100482700","NCT05565443","MR-guided Focused Ultrasound Plus GCase","A Phase I\u002FII Study for Bilateral Putamenal Delivery of Recombinant Glucocerebrosidase in Patients With Parkinson's Disease Using MR-guided Focused Ultrasound Induced Opening of the Blood-brain Barrier","Inclusion Criteria:\n\n* Men or women between age 35 and 80 years, inclusive.\n* Able and willing to give informed consent.\n* Diagnosis of PD satisfying MDS Clinical Diagnostic Criteria for PD\n* At least 2 years from initial diagnosis\n* Hoehn and Yahr Stage 1-3 on PD medication\n* Dopaminergic deficit by a positive DAT SPECT scan\n* On stable regimen of PD medications for at least 90 days prior to the study\n* American Society of Anesthesiologists (ASA) score 1-3\n* Harbor at least one GBA mutation if enrolled in the GBA PD arm or two wild-type GBA alleles if enrolled in the idiopathic PD arm\n\nExclusion Criteria:\n\n* Positive pregnancy test (for pre-menopausal women).\n* Contraindication to DEFINITY ultrasound contrast agent or perflutren (e.g. hypersensitivity, known left or bidirectional cardiac shunt)\n* Contraindication to MRI or gadolinium-DTPA (e.g. incompatible device, hypersensitivity)\n* Insulin-dependent diabetes mellitus that is not well-controlled or that in the Investigator's opinion precludes participation in the study.\n* Severely impaired renal function with estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m2 and\u002For on dialysis.\n* Currently participating in another clinical therapeutic trial\n* Patient receiving bevacizumab (Avastin) therapy\n* Subjects with evidence of cranial or systemic infection.\n* Cerebral or systemic vasculopathy.\n* Documented cerebral infarction within the past 12 months or TIA in the past 1 month.\n* Contraindication to GCase enzyme therapy, specifically previous hypersensitivity reaction to GCase enzyme therapy\n* Parkinsonism plus symptoms, secondary parkinsonism\n* Previous neurosurgical procedure for PD","35 Years","80 Years",{"count":182,"type":20},14,[23],"The goal of this study is to establish safety and feasibility of intracerebral delivery of GCase via MRgFUS. This technique may offer potential benefits given the exposure of the putamen to GCase in animal models has been shown to be efficacious in improving Parkinson's disease pathology and phenotype.",[145],[187,188,189],"Parkinson's disease","Glucocerebrosidase","GCase","2026-01-22",{"date":192,"type":31},"2026-01-23",{"date":194,"type":31},"2022-11-30",{"date":196,"type":20},"2028-12-31",{"name":37,"class":38},1,{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":206,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":5},"100337318","exablate-blood-brain-barrier-bbb-disruption-for-the-treatment-of-alzheimers-disease-100337318","NCT03671889","ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease","Assessment of Safety and Efficacy of ExAblate Blood-Brain Barrier Disruption for the Treatment of Patients With Probable Alzheimer's Disease","Inclusion Criteria:\n\n1. Male or Female between 50-85 years of age\n2. Probable Alzheimer's Disease (AD)\n3. If taking concurrent Alzheimer's medication, has been on the medication for at least 2 months with a stable dose for at least 3 months\n4. Able to communicate sensations during the ExAblate MRgFUS procedure\n5. Ambulatory\n\nExclusion Criteria:\n\n1. MRI Findings\n2. Presence of unknown or MR unsafe devices anywhere in the body\n3. Significant cardiac disease or unstable hemodynamic status\n4. Relative contraindications to ultrasound contrast agent or PET amyloid tracer\n5. History of a bleeding disorder\n6. History of liver disease\n7. Known cerebral or systemic vasculopathy\n8. Significant depression and at potential risk of suicide\n9. Any contraindications to MRI scanning\n10. Any contraindication to lumbar puncture for collection of cerebral spinal fluid\n11. Untreated, uncontrolled sleep apnea\n12. History of seizure disorder or epilepsy\n13. Severely Impaired renal function\n14. Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research\n15. Chronic pulmonary disorders\n16. Positive human immunodeficiency virus (HIV)\n17. Known apolipoprotein E allele (ApoE4) homozygosity","50 Years","85 Years",{"count":162,"type":20},[23],"The purpose of this study is to evaluate the safety and efficacy of the ExAblate Model 4000 Type 2.0 System as a tool to disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).",[212],"Alzheimer Disease",[212,214,215,216,217],"Alzheimer Syndrome","Magnetic Resonance guided Focal Ultrasound (MRgFUS)","Blood-Brain Barrier","ExAblate","2026-01-08",{"date":220,"type":31},"2026-01-09",{"date":222,"type":31},"2018-09-28",{"date":224,"type":20},"2030-01",{"name":37,"class":38},{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":232,"minAge":17,"maxAge":206,"enrollmentInfo":233,"targetDuration":235,"studyType":140,"phases":4,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":248,"locationsCount":249},"100468963","post-exablate-pregnancy-outcomes-registry-study-exablate-treatment-of-symptomatic-uterine-fibroids-100468963","NCT05386615","Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids","Inclusion Criteria: - - Eligibility is as per the symptomatic fibroids device indication. - All registry-consented patients following the treatment of their fibroid(s) with the Exablate system. Exclusion Criteria: -","FEMALE",{"count":234,"type":20},200,"2 Years","The goal of this Registry Study is to capture clinical pregnancy outcomes and fibroid treatment background data for any subject post-Exablate treatment for their symptomatic fibroids.",[238],"Uterine Fibroid",[240,241],"Uterine Fibroids","Exablate","2025-04-29",{"date":244,"type":31},"2025-04-30",{"date":246,"type":31},"2016-02-16",{"date":64,"type":20},{"name":37,"class":38},6,""]