NCT06849258 · Rivermark Medical
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
(RAPID-III)
What this study is about
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).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Bakersfield, California
- Beverly Hills, California
- La Mesa, California
- Los Angeles, California
- Montebello, California
- Tustin, California
- Littleton, Colorado
- Daytona Beach, Florida
- Lisle, Illinois
- Lafayette, Louisiana
- Troy, Michigan
- Las Vegas, Nevada
And 6 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations