[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607871":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":56,"collaborators":31,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":31,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":85,"whyStopped":31,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with benign prostatic hyperplasia","EXPERIMENTAL","HIFU therapy for benign prostatic tissue ablation in patients with lower urinary tract symptoms (LUTS) due to bladder outlet obstruction",[13],"Device: High Intensity Focused Ultrasound",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","High Intensity Focused Ultrasound","High Intensity Focused Ultrasound (HIFU) works with an image-guided transrectal probe that utilizes 3-10 MHz ultrasound waves at very high powers (200W). These waves can be very precisely directed at target tissue. Through both thermal and mechanical forces (shearing motion and mechanical energy leading to hyperthermia) the focal point core temperature can be raised significantly (\\> 80°C) leading to coagulative necrosis to the target tissue while sparing surrounding tissue. The degree of tissue injury is based on the temperature and the duration of exposure, with the cooling off time allowing for the heat to dissipate to prevent the damage to surrounding tissues. The most common device involves a transrectal transducer with ultrasound guidance that can be performed under either general or spinal anesthesia. The device has been FDA approved to be used in ablation of prostatic tissue since 2018.",[9],[21],"HIFU",[23],{"name":24,"affiliation":5,"role":25},"Michael Palese, MD","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Monali Fatterpekar","CONTACT","(212) 241-0751",null,"monali.fatterpekar@mountsinai.org",{"name":34,"role":29,"phone":31,"phoneExt":31,"email":35},"Ping Ting Yan","PingTing.Yan@mountsinai.org",[37],{"facility":38,"status":31,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Mount Sinai Union Square","New York","10003","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-74.00597,40.71427,{"lat":47,"lon":46},[50,54],{"name":51,"role":29,"phone":52,"phoneExt":31,"email":53},"Maritza Cales","(212) 844-6239","Maritza.cales@mountsinai.org",{"name":55,"role":25,"phone":31,"phoneExt":31,"email":31},"Michael Palese",{"type":25,"investigatorFullName":55,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Professor, Site Chair Department of Urology","100607871","high-intensity-focused-ultrasound-hifu-ablation-for-treatment-of-prostate-tissue-in-bladder-outlet-obstruction-100607871",false,"NCT07194187","High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction","HIFU for BOO","Inclusion Criteria:\n\n* Males aged 45 - 80 diagnosed with LUTS due to BOO from BPH.\n* Prostate size \\> 30cc and \\\u003C 80cc as measured by transrectal ultrasound (TRUS) or MRI within 1 year prior to treatment.\n* A documented history of refusal to take medical therapy, inadequate or failed response to medical therapy, or contraindications to medical therapy.\n* Initial baseline International Prostate Symptom Score (IPSS) greater than or equal to 12 which denotes moderate to severe symptoms.\n* Baseline peak urinary flow rate (Qmax) of less than 15 mL\u002Fs1\n* Baseline serum creatinine \\\u003C 2 mg\u002FdL within 30 days prior to surgery\n* Mental capacity, willingness, and ability to sign a study specific informed consent form\n\nExclusion Criteria :\n\n* BMI \\> 42\n* Patients with an obstructing prostatic median lobe as measured by baseline preliminary imaging and\u002For confirmed on cystoscopy examination.\n* Patients with latex allergies which would permit latex catheterization perioperatively as silicone catheterization is not recommended during HIFU treatment.\n* Patients with extensive calcification in the treatment area of the prostate as measured by preoperative imaging with TRUS or MRI and as evaluated by hospital radiology or the principal investigator. Extensive calcification is defined as where the calcification in posterior peripheral zone, which may interfere with experimental treatment procedure, and it is determined by hospital radiologist and further assessed by the PI.\n* Patient unable to stop anticoagulants, antiplatelet agents, or NSAIDS (including aspirin \\> 100mg) prior to treatment which is standard of care.\n* Patients using immunosuppressants including corticosteroids (except inhalants) who are unable to withhold medications prior to treatment which is standard of care.\n* Known and documented coagulopathy or platelet disorder\n* Contraindication to both general and spinal anesthesia which are standard of care.\n* Severe illness that would prevent complete study participation.\n* History of active or prior treatments for current\u002Fsuspected PCa.\n* Diagnosis of polyneuropathy\n* Bladder calculi or bladder diverticulum (pouch size \\> 20% of full bladder size)\n* Active infection, including urinary tract infection or prostatitis.\n* Evidence of hydronephrosis on imaging.\n* Pre-op urinary catheter uses daily.\n* Previous urinary tract surgeries such as, but not limited to prior surgery for LUTS, urinary diversion, artificial urinary sphincter, or penile prosthesis.\n* Diagnosis of clinically significant urethral stricture, meatal stenosis, severe phimosis, or bladder neck contracture\n* Known damage to the external urinary sphincter.\n* Open heart surgery or cardiac arrest \\\u003C 180 days prior to the date of informed consent\n* Known illicit substance abuse.\n* Use of anticholinergics (specifically for bladder problems). Use of general anticholinergics is allowed if they do not have documented adverse urinary side effects.\n* Dementia or psychiatric conditions which prevent them from completing the required follow up.\n* Prior pelvic radiotherapy\n* Participation in another ongoing investigational study that could affect responses.\n* Unwillingness to accept a transfusion should it be required.\n* No members of vulnerable populations will be included in our study.\n* History or current diagnosis of chronic prostatitis.\n* Diagnosis or prior treatment for chronic pelvic pain syndrome.","MALE","45 Years","80 Years",{"count":69,"type":70},17,"ESTIMATED","INTERVENTIONAL",[73],"NA","Objectives: To assess the efficacy of HIFU therapy for benign prostatic tissue ablation in patients with lower urinary tract symptoms (LUTS) due to bladder outlet obstruction (BOO) that caused by Benign prostatic hyperplasia (BPH).\n\nThe primary objective of the study is to determine the efficacy of HIFU therapy by assessing the changes in IPSS score in 6-month post HIFU procedure for BPH with compared to baseline.\n\nThe secondary objectives of this study are as follow:\n\n* To assess any adverse events related to the procedure or device.\n* To assess the operation related characteristics including: total operation time and ablation time required in HIFU procedure for BPH, total catheterization time after the HIFU procedure for BPH, and categorical ablation zone\n* To assess the patient's post operative pain level at different post op time points.\n* To assess the urinary flow and symptoms improvement by studying the changes in IPSS, Qmax, and PVR at different post op time points compared to the baseline.\n* To assess the effectiveness of HIFU by studying the changes in PSA levels, types of medication for BPH or any urologic condition, proportion of patients who are taking BPH medication, prostate volume, and prostate calcification level and the reoperation rate within 12-month post-op.\n* To assess changes in patients' sexual function at different post op time points.\n\nThe hypothesis is that a HIFU ablation is a safe and effective treatment for patients with LUTS due to BOO from BPH.",[76,77],"Bladder Outlet Obstruction","BPH",[79,80,81,82,83,84],"High-intensity focused ultrasound","Interventional","Single Arm","benign prostatic hyperplasia treatment","International Prostate Symptom Score","Device Safety","NOT_YET_RECRUITING","2026-04-03",{"date":88,"type":89},"2026-04-09","ACTUAL",{"date":91,"type":70},"2026-06-01",{"date":93,"type":70},"2027-09-20",{"name":5,"class":6},1]