NCT06849258 A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
| NCT ID | NCT06849258 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rivermark Medical |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 215 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2032-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 215 participants in total. It began in 2025-02-10 with a primary completion date of 2032-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Male subjects \> 45 years of age who have symptomatic BPH * 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: * Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate * 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)
Contact & Investigator
Study Director, MD
STUDY DIRECTOR
Rivermark Medical, Inc.
Frequently Asked Questions
Who can join the NCT06849258 clinical trial?
This trial is open to male participants only, aged 45 Years or older, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06849258 currently recruiting?
Yes, NCT06849258 is actively recruiting participants. Contact the research team at info@rivermarkmedical.com for enrollment information.
Where is the NCT06849258 trial being conducted?
This trial is being conducted at Bakersfield, United States, Beverly Hills, United States, La Mesa, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06849258 clinical trial?
NCT06849258 is sponsored by Rivermark Medical. The principal investigator is Study Director, MD at Rivermark Medical, Inc.. The trial plans to enroll 215 participants.