NCT06849258

A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms

A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of The FloStent in Men Suffering From Benign Prostatic Hyperplasia Symptoms

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 215 (estimated)
• Sponsor: Rivermark Medical · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	FloStent	Flexible cystoscopy to deploy medical device used to treat BPH
DEVICE	Sham (Control)	Flexible Cystoscopy without deployment of medical device used to treat BPH

Timeline

• Start date: 2025-02-10
• Primary completion: 2032-12-31
• Completion: 2032-12-31
• First posted: 2025-02-27
• Last updated: 2025-04-27

Locations

20 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated device study