RECRUITING

OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

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Conditions

Benign Prostatic HyperplasiaBPHDrug Coated BalloonDCBProstateLUTSOptilume

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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

APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.

Official Title

A Prospective Multi-site Registry of Real-world Experience With the OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

Quick Facts

Study Start:2024-03-30
Study Completion:2027-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06560476

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:Not specified
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU).
  1. 1. Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure
  2. 2. Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
  3. 3. Confirmed or suspected malignancy of prostate or bladder.
  4. 4. Active urinary tract infection (UTI)
  5. 5. Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System

Contacts and Locations

Study Contact

Brandon Shuler
CONTACT
7012201710
bshuler@laborie.com
Reem Ennenga
CONTACT
61274741836
rennenga@laborie.com

Study Locations (Sites)

Kearney Urology Center
Kearney, Nebraska, 68847
United States
Adult & Pediatric Urology, PC
Omaha, Nebraska, 68144
United States
Good Samaritan Hospital
Corvallis, Oregon, 97330
United States
Potomac Urology
Woodridge, Virginia, 22191
United States

Collaborators and Investigators

Sponsor: Urotronic 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 Date2024-03-30
Study Completion Date2027-03-30

Study Record Updates

Study Start Date2024-03-30
Study Completion Date2027-03-30

Terms related to this study

Keywords Provided by Researchers

  • BPH
  • Drug Coated Balloon
  • DCB
  • Prostate
  • LUTS
  • Optilume

Additional Relevant MeSH Terms

  • Benign Prostatic Hyperplasia