A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
Recruiting
N/A
Interventional Study
Benign Prostatic Hyperplasia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 45 and older
- Sex
- Male
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 215 (estimated)
- Sponsor
- Rivermark Medical · Industry
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About This Trial
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…
Trial Locations
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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 …
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