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

NCT06849258 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2025-04-27

No results posted yet for this 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.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

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

Sponsors & Collaborators

  • Rivermark Medical

    lead INDUSTRY

Principal Investigators

  • Study Director, MD · Rivermark Medical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2032-12-31
Completion
2032-12-31
FDA Device
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06849258 on ClinicalTrials.gov