A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
NCT ID: NCT06849258
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
215 participants
INTERVENTIONAL
2025-02-10
2032-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment - FloStent
Flexible cystoscopy procedure with FloStent implant deployed
FloStent
Flexible cystoscopy to deploy medical device used to treat BPH
Sham Control
Flexible cystoscopy procedure without FloStent implant deployed
Sham (Control)
Flexible Cystoscopy without deployment of medical device used to treat BPH
Interventions
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FloStent
Flexible cystoscopy to deploy medical device used to treat BPH
Sham (Control)
Flexible Cystoscopy without deployment of medical device used to treat BPH
Eligibility Criteria
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Inclusion Criteria
* International Prostate Symptom Score (IPSS) score \>13
* Peak urinary flow rate (Qmax): \>5 mL/sec and \<13 mL/sec with minimum voided volume of \>125 mL
* Post-void residual (PVR) \<250 mL
* Prostate volume 25 to 80 mL
* Prostatic urethral length 20-50 mm
* Able to complete the study protocol and visits
Exclusion Criteria
* Prior minimally invasive intervention or surgical intervention of the prostate or urethra
* PSA \>10 ng/mL
* Bladder cancer or bladder stones
* Active urinary tract infection (UTI)
* Uncontrolled diabetes
* Part of a vulnerable population (cognitively challenged or are incarcerated)
45 Years
MALE
No
Sponsors
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Rivermark Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director, MD
Role: STUDY_DIRECTOR
Rivermark Medical, Inc.
Locations
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Michael G Oefelein Clinical Trials
Bakersfield, California, United States
Comprehensive Urology Medical Group
Beverly Hills, California, United States
Atlas Men's Health
La Mesa, California, United States
Urology Group of Southern California
Los Angeles, California, United States
Prestige Medical Group
Tustin, California, United States
Urology Denver
Littleton, Colorado, United States
Advanced Urology Institute
Daytona Beach, Florida, United States
Duly Health
Lisle, Illinois, United States
Loyola Medicine
Maywood, Illinois, United States
Southern Urology
Lafayette, Louisiana, United States
Michigan Institute of Urology
Troy, Michigan, United States
Sheldon Freedman Urology
Las Vegas, Nevada, United States
Manhattan Medical Research NYU Langone
New York, New York, United States
Northwell Health
Syosset, New York, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
Conrad Pearson Clinic
Germantown, Tennessee, United States
Midtown Urology Associates
Austin, Texas, United States
Urology Austin/Urology America
Austin, Texas, United States
Houston Methodist
Houston, Texas, United States
South Coast Urology
Wollongong, New South Wales, Australia
Countries
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Central Contacts
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Other Identifiers
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C0002 Rev. 07
Identifier Type: -
Identifier Source: org_study_id
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