Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 22
Maximum Age: 65
Healthy Volunteers: f
View:

• Male subjects between 22 and 65 years of age

• 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

• Subject is willing to provide written informed consent and comply with study required follow-up assessments

• Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples):

‣ total sperm ≥39 million

⁃ sperm concentration ≥15 million/mL

⁃ total motility ≥40%

⁃ progressive motility ≥32%

⁃ morphology ≥4%

Locations
United States
Arkansas
Arkansas Urology
RECRUITING
Little Rock
Florida
Orlando Health
RECRUITING
Orlando
Florida Urology
RECRUITING
Tampa
Louisiana
Regional Urology
COMPLETED
Shreveport
Maryland
Chesapeake
COMPLETED
Hanover
New Jersey
New Jersey Urolgy
COMPLETED
Millburn
Nevada
Freedman Urology
RECRUITING
Las Vegas
New York
Western New York
RECRUITING
Cheektowaga
Texas
Urology Clinics of North Texas
RECRUITING
Dallas
Contact Information
Primary
Brenda Johnson, MS
bjohnson@laborie.com
Backup
Reem Ennenga
rennenga@laborie.com
612-747-4183
Time Frame
Start Date: 2022-02-14
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 34
Treatments
Experimental: Optilume Urethral DCB
The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.
Related Therapeutic Areas
Sponsors
Collaborators: Laborie Medical Technologies Inc.
Leads: Urotronic Inc.

This content was sourced from clinicaltrials.gov

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