[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MedtronicNeuro\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":85},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,61],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"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},"100628071","post-approval-effectiveness-and-durability-evaluation-of-the-altaviva-tibial-device-100628071",false,"NCT07456865","Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device","ENDURANCE™","Inclusion Criteria:\n\n1. Candidate for Altaviva™ therapy per Altaviva™ labeling\n2. Have a diagnosis of UUI as demonstrated on a 3-day voiding diary by having a minimum of 3 episodes of urinary urge incontinence in 72 hours\n3. If taking OAB medications, subjects should be on a stable dose for at least 3 months prior to baseline and willing to remain on stable treatment through completion of the 12-month voiding diary\n4. Patient must be willing and able to accurately complete study questionnaires, attend visits, operate the system, and comply with the study protocol\n5. Willing and able to provide signed and dated informed consent\n\nExclusion Criteria:\n\n1. Patient who is not a candidate for Altaviva™ therapy per Altaviva™ labeling, including:\n\n   * Patients who are considered to be poor surgical candidates or who are at risk for poor wound healing per Altaviva™ labeling\n   * Have progressive, systemic neurological disease\n   * Have clinically significant peripheral neuropathy in the lower leg\n   * Severe, uncontrolled diabetes\n2. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component based on physician judgment\n3. Current symptomatic urinary tract infection\n4. Patients who have been treated with percutaneous tibial nerve stimulation (PTNS)\u002Fpercutaneous tibial neuromodulation (PTNM) therapy in the past 4 weeks, or longer if the investigator judges that the therapeutic effect is still present\n5. Patients who have had treatment of urinary symptoms with botulinum toxin therapy or sacral neuromodulation in the past 6 months\n6. History of a prior implantable tibial neuromodulation system\n7. Patients who are pregnant or planning to become pregnant during the course of the study\n8. Patient is currently enrolled or plans to enroll in concurrent drug\u002Fdevice study that may confound study results","ALL","18 Years",{"count":19,"type":20},256,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this prospective, multicenter study is to assess the long-term safety and effectiveness of the Altaviva™ system for the treatment of UUI",[26],"Urge Urinary Incontinence","RECRUITING","2026-06-24",{"date":30,"type":31},"2026-06-26","ACTUAL",{"date":33,"type":31},"2026-03-17",{"date":35,"type":20},"2032-11",{"name":37,"class":38},"MedtronicNeuro","INDUSTRY",8,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":54,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":60},"100609622","adaptive-dbs-algorithm-for-personalized-therapy-in-parkinsons-disease-adapt-pd-china-study-100609622","NCT07216976","Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study","Inclusion Criteria:\n\n1. Subjects must meet all general inclusion\u002Fexclusion criteria (as assessed at the Enrollment Visit)\n2. Subjects must meet the LFP screening inclusion criterion (as assessed at the LFP Screening Visit)\n\nGeneral (Assessed at Enrollment Visit):\n\n1. Subject has idiopathic Parkinson's disease\n2. Subject is implanted (\\>3 months prior to enrollment for new INS implants or \\>1 month from INS replacement) with a Percept PC (Model B35200) or Percept RC (Model B35300) and Medtronic DBS leads (Model 3387, 3389, B33005 or B33015) and extensions (Model 37086 or B34000) bilaterally in the same target (physician confirmed), STN or GPi\n3. In the opinion of the investigator, the subject responds to DBS Therapy.\n4. Based on the opinion of the investigator, the subject's cDBS parameters and PD medications are stable (no changes within the last 4 weeks) and expected to remain stable from enrollment through the end of the aDBS Evaluation Phase\n5. Subject is configured to monopolar or dual monopolar stimulation using contacts 1 and\u002For 2 (9 and\u002For 10) on at least one side\n6. Subject is willing and able to attend all study-required visits and complete the study procedures (e.g. 1-month recall questionnaires, MDS-UPDRS III, Off stim\u002FOff med visit)\n7. Subject (or legally authorized representative) has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted\n8. Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator\n\nLFP Screening Inclusion Criteria (Conducted during LFP Screening Visit):\n\n1\\. Subject has Alpha - Beta band (8-30 Hz) amplitude ≥ 1.2 μVp detected on either left and\u002For right DBS leads on sensing channels 0-2, 0-3, 1-3, 8-10, 8-11, or 9-11.\n\nExclusion Criteria:\n\nGeneral (Assessed at the Enrollment Visit):\n\n1. Subject and\u002For caregiver is unable to utilize the patient programmer\n2. Subject has more than one lead in each hemisphere of the brain\n3. Subject has cortical leads or additional unapproved hardware implanted in the brain\n4. Subject has more than one INS\n5. At enrollment, the subject's INS has a predicted battery life of \\\u003C1 year\n6. Subject has Beck Depression Inventory II (BDI-II)\\>25\n7. Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)\n8. Subject has a metallic implant in the head, (e.g., aneurysm clip, cochlear implant)\n9. Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemaker, defibrillator, spinal cord stimulator)\n10. Subject has, or plans to obtain, an implanted medication pump for the treatment of Parkinson's disease (e.g., DUOPATM infusion pump) and\u002For portable infusion pump\n11. Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation\n12. Subject is breast feeding\n13. Subject is under the age of 18 years\n14. Subject is currently enrolled in or plans to enroll in any concurrent drug and\u002For device study that may confound the results of this study as determined by the Medtronic study team\n15. Subjects with signal artifact on all 6 aDBS sense pathways (3 each on both DBS leads) which preclude the clinician from setting thresholds",{"count":47,"type":20},62,[23],"The purpose of the study is to evaluate the effectiveness of the Medtronic Adaptive DBS therapy (aDBS) for Parkinson's Disease in China with the Percept family of Implantable Neurostimulators (Percept PC and Percept RC).",[51],"Parkinson's Disease",[53],"Deep Brain Stimulation",{"date":30,"type":31},{"date":56,"type":31},"2025-11-19",{"date":58,"type":20},"2028-01",{"name":37,"class":38},5,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100454698","pelvic-health-electrically-evoked-recording-peer-2-study-100454698","NCT05200923","Pelvic Health Electrically Evoked Recording (PEER) 2 Study","PEER 2","Inclusion Criteria:\n\nOveractive Bladder Criteria Inclusion Criteria\n\n1. 18 years of age or older\n2. Candidate for or undergoing Medtronic InterStim lead implant for labeled indication\\* requiring an advanced evaluation\n3. Willing and able to provide signed and dated informed consent\n4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol\n5. Willing to maintain current regimen (dosage and frequency) of any OAB medication from baseline diary through the end of therapy evaluation\n6. For subjects with urinary urge incontinence, have a diagnosis of OAB as demonstrated on a voiding diary by having a minimum of 3 episodes of urinary urge incontinence in the first 72 hours (Episodes must have a mild, moderate, or severe degree of urgency to meet this criterion) of the voiding diary.\n7. For subjects with urinary frequency, have a diagnosis of OAB as demonstrated on a voiding diary with greater than or equal to 8 urgency frequency episodes per day within the first 72 hours of the voiding diary.\n\nNote\\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.\n\nNon-Obstructive Urinary Retention Inclusion Criteria\n\n1. 18 years of age or older\n2. Candidate for or undergoing Medtronic InterStim lead implant for labeled indication\\* requiring an advanced evaluation\n3. Willing and able to provide signed and dated informed consent\n4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol\n5. Willing to maintain current regimen (dosage and frequency) of any NOUR medication from baseline diary through the end of therapy evaluation\n6. Have a diagnosis of non-obstructive urinary retention with an elevated postvoid residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions.\n\nNote\\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.\n\nFecal Incontinence Inclusion Criteria\n\n1. 18 years of age or older\n2. Candidate for or undergoing Medtronic InterStim lead implant labeled indication\\* requiring an advanced evaluation\n3. Willing and able to provide signed and dated informed consent\n4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol\n5. Willing to maintain current regimen (dosage and frequency) of any FI medication from baseline diary through the end of therapy evaluation\n6. Have a diagnosis of fecal incontinence as demonstrated by 3-day a bowel diary as greater than or equal to 1 incontinent episode of more than staining (i.e., either slight, moderate, or severe soiling)\n\nNote\\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.\n\nExclusion Criteria:\n\nOveractive Bladder Criteria Exclusion Criteria\n\n1. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)\n2. Implanted with a neurostimulator, pacemaker or defibrillator\n3. Pelvic floor muscle dysfunction due to surgical intervention or injury\n4. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)\n5. History of diabetes unless the diabetes is well-controlled through diet and\u002For medications\n6. Have symptomatic urinary tract infection (UTI)\n7. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component\n8. Treatment of voiding behavior with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study\n9. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months\n10. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study\n11. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy\n12. Women who are pregnant or planning to become pregnant\n13. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)\n14. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements\n\nNon-Obstructive Urinary Retention Exclusion Criteria\n\n1. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)\n2. Implanted with a neurostimulator, pacemaker or defibrillator\n3. Pelvic floor muscle dysfunction due to surgical intervention or injury\n4. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)\n5. History of diabetes unless the diabetes is well-controlled through diet and\u002For medications\n6. Have symptomatic urinary tract infection (UTI)\n7. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months\n8. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study\n9. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy\n10. Women who are pregnant or planning to become pregnant\n11. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)\n12. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements\n\nFecal Incontinence Exclusion Criteria\n\n1. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)\n2. Implanted with a neurostimulator, pacemaker or defibrillator\n3. Pelvic floor muscle dysfunction due to surgical intervention or injury\n4. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)\n5. Have uncorrected high grade internal rectal prolapse\n6. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months\n7. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study\n8. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy\n9. Women who are pregnant or planning to become pregnant\n10. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements",{"count":69,"type":20},300,[23],"To collect physiological signals at several timepoints during the therapy evaluation period.",[73,74,75],"Overactive Bladder","Fecal Incontinence","Urinary Retention","2026-03-02",{"date":78,"type":31},"2026-03-03",{"date":80,"type":31},"2022-01-18",{"date":82,"type":20},"2026-12-18",{"name":37,"class":38},7,""]