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NCT06849258 · ClinicalTrials.gov registry record · NA

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

A NA study of Benign Prostatic Hyperplasia, sponsored by Rivermark Medical.

Recruiting
Registry status
NA
Development phase
215
Enrollment target
20
Study locations

NCT06849258 is a NA study of Benign Prostatic Hyperplasia that is actively recruiting participants, run by Rivermark Medical. The registered enrollment target is 215 participants, below the 545-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT06849258, a NA study of Benign Prostatic Hyperplasia, is actively recruiting participants, sponsored by Rivermark Medical.

RECRUITING
Registry status
NA
Development phase
215 participants
Enrollment target
20
Study locations

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 Studied

Benign Prostatic Hyperplasia

Interventions

  • DEVICE FloStent
  • DEVICE Sham (Control)

Study Locations (20)

California

  • Michael G Oefelein Clinical Trials - Bakersfield
  • Comprehensive Urology Medical Group - Beverly Hills
  • Atlas Men's Health - La Mesa
  • Urology Group of Southern California - Los Angeles
  • Prestige Medical Group - Tustin

Texas

  • Midtown Urology Associates - Austin
  • Urology Austin/Urology America - Austin
  • Houston Methodist - Houston

Illinois

  • Duly Health - Lisle
  • Loyola Medicine - Maywood

New York

  • Manhattan Medical Research NYU Langone - New York
  • Northwell Health - Syosset

Colorado

  • Urology Denver - Littleton

Florida

  • Advanced Urology Institute - Daytona Beach

Louisiana

  • Southern Urology - Lafayette

Michigan

  • Michigan Institute of Urology - Troy

Trial Details

FieldValue
Enrollment Target 215 participants
Start Date 2025-02-10
Est. Completion 2032-12-31
Phase NA

Sponsor

Rivermark Medical

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06849258

The ClinicalTrials.gov registry entry for NCT06849258 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 545-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (61% lower). The listed sponsor is Rivermark Medical, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Benign Prostatic Hyperplasia appearing as the primary indexed condition, and to 2 interventions - of which FloStent is the first listed.

NCT06849258 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Texas, Illinois.

Frequently Asked Questions

What is clinical trial NCT06849258 about?

NCT06849258 is a clinical study titled "A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms". 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 random...

What is the current status of trial NCT06849258?

This trial is currently recruiting. It is a NA study. The enrollment target is 215 participants. The study started on 2025-02-10. Estimated completion is 2032-12-31.

What conditions does trial NCT06849258 study?

This clinical trial studies the following conditions: Benign Prostatic Hyperplasia.

What interventions are being tested in trial NCT06849258?

The interventions under investigation include: FloStent (DEVICE), Sham (Control) (DEVICE).

Who is sponsoring clinical trial NCT06849258?

This trial is sponsored by Rivermark Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06849258 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.