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NCT06849258 · ClinicalTrials.gov registry record · NA
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
A NA study of Benign Prostatic Hyperplasia, sponsored by Rivermark Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 215
- Enrollment target
- 20
- Study locations
NCT06849258: Recruiting NA study of Benign Prostatic Hyperplasia, sponsored by Rivermark Medical.
NCT06849258 is a NA study of Benign Prostatic Hyperplasia that is actively recruiting participants, run by Rivermark Medical. The registered enrollment target is 215 participants, below the 545-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06849258, a NA study of Benign Prostatic Hyperplasia, is actively recruiting participants, sponsored by Rivermark Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 215 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
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). The 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): 0-7 mildly symptomatic 8-19 moderately symptomatic 20-35 severely symptomatic
Conditions Studied
Interventions
- DEVICE FloStent
- DEVICE Sham (Control)
Study Locations (20)
California
- Michael G Oefelein Clinical Trials - Bakersfield
- Comprehensive Urology Medical Group - Beverly Hills
- Atlas Men's Health - La Mesa
- Urology Group of Southern California - Los Angeles
- Prestige Medical Group - Tustin
Texas
- Midtown Urology Associates - Austin
- Urology Austin/Urology America - Austin
- Houston Methodist - Houston
Illinois
- Duly Health - Lisle
- Loyola Medicine - Maywood
New York
- Manhattan Medical Research NYU Langone - New York
- Northwell Health - Syosset
Colorado
- Urology Denver - Littleton
Florida
- Advanced Urology Institute - Daytona Beach
Louisiana
- Southern Urology - Lafayette
Michigan
- Michigan Institute of Urology - Troy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2025-02-10 |
| Est. Completion | 2032-12-31 |
| Phase | NA |
What NCT06849258 shows while recruiting
NCT06849258 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 545-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Benign Prostatic Hyperplasia appearing as the primary indexed condition, and to 2 interventions - of which FloStent is the first listed.
NCT06849258 names 20 study sites across 12 states, led by California, Texas, Illinois.
Frequently Asked Questions
What is clinical trial NCT06849258 about?
NCT06849258 is a clinical study titled "A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms". 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 random...
What is the current status of trial NCT06849258?
This trial is currently recruiting. It is a NA study. The enrollment target is 215 participants. The study started on 2025-02-10. Estimated completion is 2032-12-31.
What conditions does trial NCT06849258 study?
This clinical trial studies the following conditions: Benign Prostatic Hyperplasia.
What interventions are being tested in trial NCT06849258?
The interventions under investigation include: FloStent (DEVICE), Sham (Control) (DEVICE).
Who is sponsoring clinical trial NCT06849258?
This trial is sponsored by Rivermark Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06849258 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06849258's enrollment target sits among peer trials
215 10th of 29 higher than 20 of 29 other Benign Prostatic Hyperplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Benign Prostatic Hyperplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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