Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT04997369
Status:
SUSPENDED
Last Update Posted:
2024-12-30
First Post:
2021-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Catheterless Water Vapor Therapy for the Treatment of BPH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'whyStopped': 'Principal Investigator changing locations.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-26', 'studyFirstSubmitDate': '2021-07-29', 'studyFirstSubmitQcDate': '2021-08-05', 'lastUpdatePostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Catheterless Rezum as measured by changes in the International Prostate Symptom Score (IPSS).', 'timeFrame': 'Baseline, 36 months', 'description': 'The outcome will be assessed based on a 6.0-point average improvement in the IPSS score. Higher scores indicate greater symptom severity and lower scores indicate less symptom severity.'}, {'measure': 'Feasibility of Catheterless Rezum as measured by changes in the maximum urinary flow rate (Qmax).', 'timeFrame': 'Baseline, 36 months', 'description': 'The outcome will be assessed based on a 2.5-point average improvement in Qmax compared to baseline. Higher Qmax values indicate less urinary obstruction while lower Qmax values correspond to increased urinary obstruction.'}], 'secondaryOutcomes': [{'measure': 'Changes in urinary symptoms as measured by changes in IPSS.', 'timeFrame': 'Baseline, 36 months', 'description': 'The outcome will be assessed based on a 6.0-point average improvement in the IPSS score. Higher scores indicate greater symptom severity and lower scores indicate less symptom severity.'}, {'measure': 'Changes in urinary symptoms as measured by changes in Qmax at 36 months', 'timeFrame': 'Baseline, 36 months', 'description': 'The outcome will be assessed based on a 2.5-point average improvement in Qmax compared to baseline. Higher Qmax values indicate less urinary obstruction while lower Qmax values correspond to increased urinary obstruction.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Water Vapor Therapy'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH). One of the limitations of the technology is the need for post-operative catheterization up to 5 days. The aim of this study is to assess the feasibility of employing Catheterless Rezum post-operatively in patients with normal or strong bladder contractility. Upon a positive outcome of interim analysis, the effectiveness of Catheterless Rezum will be assessed at five sites for the multicenter phase.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subject of 40 - 80 years of age\n* Has provided informed consent\n* Has a diagnosis of bladder outlet obstruction due to benign prostatic enlargement\n* Able to complete self-administered questionnaires\n* Is a surgical candidate for Rezum\n* Has medical record documentation of Qmax \\< 15 ml/s\n* Has medical record documentation of prostate volume from 30-80 ml by transrectal ultrasound (TRUS)\n* Has a bladder contractility index score ≥ 100, calculated by detrusor pressure at Qmax (pDet@qmax) + (5xQmax).\n* Willing to undergo pressure-flow studies to calculate BCI prior to surgical intervention.\n* Has serum creatinine within the normal range.\n* Able to perform intermittent catheterization.\n\nExclusion Criteria:\n\n* Has a life expectancy \\< 2 years\n* Is currently enrolled in or plans to enroll in any concurrent drug or device study\n* Has an active infection (e.g., urinary tract infection or prostatitis)\n* Has a diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)\n* Has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days\n* Has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years\n* Has a diagnosis of lichen sclerosis\n* Has a diagnosis of neurogenic bladder or other neurologic disorder that affects bladder function\n* Has a diagnosis of polyneuropathy (e.g., diabetic)\n* Has a history of lower urinary tract surgery\n* Has a diagnosis of stress urinary incontinence that requires treatment or daily pad or device use\n* Has an inability to perform intermittent self-catheterization\n* Has been catheterized or has a post-void residual (PVR) of \\> 400 ml in the 14 days prior to the surgical procedure\n* Has a current diagnosis of bladder stones'}, 'identificationModule': {'nctId': 'NCT04997369', 'briefTitle': 'Catheterless Water Vapor Therapy for the Treatment of BPH', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Feasibility and Multicenter Assessment of Catheter-less Water Vapor Therapy (Rezum) for the Treatment of Benign Prostatic Hyperplasia (BPH)', 'orgStudyIdInfo': {'id': '20-02021474'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Catheterless group', 'interventionNames': ['Device: Rezum']}], 'interventions': [{'name': 'Rezum', 'type': 'DEVICE', 'otherNames': ['Water vapor therapy'], 'description': 'The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH).', 'armGroupLabels': ['Catheterless group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Bilal Chughtai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}