Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT06849258
Status:
RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}], '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'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized in a 2:1 (device:sham) ratio .'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 215}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2025-02-17', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in International Prostate Symptom Score (IPSS)', 'timeFrame': '12 months', 'description': "The International Prostate Symptom Score IPSS is a self-questionnaire (patient reported outcome). It contains 7 questions about symptoms related to BPH and 1 question about the patient's perceived quality of life (QoL).\n\nThe 7 questions are scored from 0 to 5. The sum of the 7 items gives the International Prostate Symptom Score in terms of severity (out of 35):\n\n0-7 mildly symptomatic 8-19 moderately symptomatic 20-35 severely symptomatic"}], 'secondaryOutcomes': [{'measure': 'Percent responders to IPSS', 'timeFrame': '3 months', 'description': 'A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.'}, {'measure': 'Percent responders to IPSS', 'timeFrame': '6 months', 'description': 'A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.'}, {'measure': 'Percent responders to IPSS', 'timeFrame': '12 months', 'description': 'A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['benign prostatic hyperplasia', 'FloStent', 'Rivermark Medical', 'BPH', 'LUTS', 'Lower urinary tract symptoms', 'enlarged prostate'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'genderBased': True, 'genderDescription': 'Male at birth and identify as male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subjects \\> 45 years of age who have symptomatic BPH\n* International Prostate Symptom Score (IPSS) score \\>13\n* Peak urinary flow rate (Qmax): \\>5 mL/sec and \\<13 mL/sec with minimum voided volume of \\>125 mL\n* Post-void residual (PVR) \\<250 mL\n* Prostate volume 25 to 80 mL\n* Prostatic urethral length 20-50 mm\n* Able to complete the study protocol and visits\n\nExclusion Criteria:\n\n* Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate\n* Prior minimally invasive intervention or surgical intervention of the prostate or urethra\n* PSA \\>10 ng/mL\n* Bladder cancer or bladder stones\n* Active urinary tract infection (UTI)\n* Uncontrolled diabetes\n* Part of a vulnerable population (cognitively challenged or are incarcerated)'}, 'identificationModule': {'nctId': 'NCT06849258', 'acronym': 'RAPID-III', 'briefTitle': 'A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rivermark Medical'}, 'officialTitle': 'A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of The FloStent in Men Suffering From Benign Prostatic Hyperplasia Symptoms', 'orgStudyIdInfo': {'id': 'C0002 Rev. 07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment - FloStent', 'description': 'Flexible cystoscopy procedure with FloStent implant deployed', 'interventionNames': ['Device: FloStent']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Control', 'description': 'Flexible cystoscopy procedure without FloStent implant deployed', 'interventionNames': ['Device: Sham (Control)']}], 'interventions': [{'name': 'FloStent', 'type': 'DEVICE', 'description': 'Flexible cystoscopy to deploy medical device used to treat BPH', 'armGroupLabels': ['Treatment - FloStent']}, {'name': 'Sham (Control)', 'type': 'DEVICE', 'description': 'Flexible Cystoscopy without deployment of medical device used to treat BPH', 'armGroupLabels': ['Sham Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Michael G Oefelein Clinical Trials', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90048', 'city': 'Beverly Hills', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Comprehensive Urology Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Atlas Men's Health", 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Urology Group of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Prestige Medical Group', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '80122', 'city': 'Littleton', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Urology Denver', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '32114', 'city': 'Daytona Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Advanced Urology Institute', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '60532', 'city': 'Lisle', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Duly Health', 'geoPoint': {'lat': 41.80114, 'lon': -88.07479}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Loyola Medicine', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '70508', 'city': 'Lafayette', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Southern Urology', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Michigan Institute of Urology', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '89144', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sheldon Freedman Urology', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Manhattan Medical Research NYU Langone', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11791', 'city': 'Syosset', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.82621, 'lon': -73.50207}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Associated Urologists of North Carolina', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Conrad Pearson Clinic', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Midtown Urology Associates', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Urology Austin/Urology America', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2500', 'city': 'Wollongong', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'facility': 'South Coast Urology', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}], 'centralContacts': [{'name': 'Study Manager Study Director, MD', 'role': 'CONTACT', 'email': 'info@rivermarkmedical.com', 'phone': '414-758-7948'}], 'overallOfficials': [{'name': 'Study Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rivermark Medical, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rivermark Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}