RECRUITING

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

Talk to us

Conditions

Benign Prostatic HyperplasiaFloStentRivermark MedicalBPHLUTSLower urinary tract symptomsenlarged prostate

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-10
Study Completion:2032-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06849258

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male subjects \> 45 years of age who have symptomatic BPH
  2. * International Prostate Symptom Score (IPSS) score \>13
  3. * Peak urinary flow rate (Qmax): \>5 mL/sec and \<13 mL/sec with minimum voided volume of \>125 mL
  4. * Post-void residual (PVR) \<250 mL
  5. * Prostate volume 25 to 80 mL
  6. * Prostatic urethral length 20-50 mm
  7. * Able to complete the study protocol and visits
  1. * Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
  2. * Prior minimally invasive intervention or surgical intervention of the prostate or urethra
  3. * PSA \>10 ng/mL
  4. * Bladder cancer or bladder stones
  5. * Active urinary tract infection (UTI)
  6. * Uncontrolled diabetes
  7. * Part of a vulnerable population (cognitively challenged or are incarcerated)

Contacts and Locations

Study Contact

Study Manager Study Director, MD
CONTACT
773-307-9665
info@rivermarkmedical.com

Principal Investigator

Study Director, MD
STUDY_DIRECTOR
Rivermark Medical, Inc.

Study Locations (Sites)

Michael G Oefelein Clinical Trials
Bakersfield, California, 93301
United States
Comprehensive Urology Medical Group
Beverly Hills, California, 90048
United States
Atlas Men's Health
La Mesa, California, 91942
United States
Urology Group of Southern California
Los Angeles, California, 90017
United States
Urology Denver
Littleton, Colorado, 80122
United States
Advanced Urology Institute
Daytona Beach, Florida, 32114
United States
Duly Health
Lisle, Illinois, 60532
United States
Loyola Medicine
Maywood, Illinois, 60153
United States
Southern Urology
Lafayette, Louisiana, 70508
United States
Michigan Institute of Urology
Troy, Michigan, 48084
United States
Sheldon Freedman Urology
Las Vegas, Nevada, 89144
United States
Manhattan Medical Research NYU Langone
New York City, New York, 10016
United States
Northwell Health
Syosset, New York, 11791
United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
United States
Conrad Pearson Clinic
Germantown, Tennessee, 38138
United States
Midtown Urology Associates
Austin, Texas, 78705
United States
Urology Austin/Urology America
Austin, Texas, 78759
United States
Houston Methodist
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Rivermark Medical

  • Study Director, MD, STUDY_DIRECTOR, Rivermark Medical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-10
Study Completion Date2032-12-31

Study Record Updates

Study Start Date2025-02-10
Study Completion Date2032-12-31

Terms related to this study

Keywords Provided by Researchers

  • benign prostatic hyperplasia
  • FloStent
  • Rivermark Medical
  • BPH
  • LUTS
  • Lower urinary tract symptoms
  • enlarged prostate

Additional Relevant MeSH Terms

  • Benign Prostatic Hyperplasia