RECRUITING

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Talk to us

Conditions

Urethral Stricture

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

Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.

Official Title

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Quick Facts

Study Start:2022-02-14
Study Completion:2026-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05383274

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:22 Years to 65 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male subjects between 22 and 65 years of age
  2. 2. Subject diagnosed with a stricture in the anterior urethra that is able to be treated with the Optilume Urethral DCB in accordance with the approved Instructions for Use
  3. 3. Subject is willing to provide written informed consent and comply with study required follow-up assessments
  4. 4. Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples):
  5. 1. total sperm ≥39 million
  6. 2. sperm concentration ≥15 million/mL
  7. 3. total motility ≥40%
  8. 4. progressive motility ≥32%
  9. 5. morphology ≥4%
  1. 1. Subjects with a known hypersensitivity to paclitaxel or structurally related compounds
  2. 2. Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function
  3. 3. Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout
  4. 4. Subject is unwilling to abstain or utilize a condom for 30 days after the procedure
  5. 5. Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential
  6. 6. History of cancer in any body system that is not considered in complete remission

Contacts and Locations

Study Contact

Brenda Johnson
CONTACT
17632857488
bjohnson@laborie.com
Reem Ennenga
CONTACT
612-747-4183
rennenga@laborie.com

Principal Investigator

Karl Coutinho, MD
PRINCIPAL_INVESTIGATOR
New Jersey Urology

Study Locations (Sites)

Arkansas Urology
Little Rock, Arkansas, 72211
United States
Orlando Health
Orlando, Florida, 32806
United States
Florida Urology
Tampa, Florida, 33615
United States
Regional Urology
Shreveport, Louisiana, 71106
United States
Chesapeake
Hanover, Maryland, 21076
United States
Freedman Urology
Las Vegas, Nevada, 89144
United States
New Jersey Urolgy
Millburn, New Jersey, 07041
United States
Western New York
Cheektowaga, New York, 14225
United States
Urology Clinics of North Texas
Dallas, Texas, 75231
United States

Collaborators and Investigators

Sponsor: Urotronic Inc.

  • Karl Coutinho, MD, PRINCIPAL_INVESTIGATOR, New Jersey Urology

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 Date2022-02-14
Study Completion Date2026-03-30

Study Record Updates

Study Start Date2022-02-14
Study Completion Date2026-03-30

Terms related to this study

Additional Relevant MeSH Terms

  • Urethral Stricture