Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Urotronic Inc.
Summary
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
Description
Male subject diagnosed with a stricture in the anterior urethra that can be treated with the Optilume Urethral DCB. Thirty-Four (34) subjects will be enrolled at up to ten (10) sites in the United States. Clinical follow-up will be conducted at 30 days, 3 months, 6 months, and 12 months post-treatment evaluating Lower Urinary Tract Symptoms (LUTS), sexual function, and voiding function. Semen quality parameters will be assessed at Baseline, 3 months, and 6 months post-treatment. Subjects with an abnormal semen quality result at 6 months will have an additional assessment at 12 months post-trea…
Eligibility
- Age range
- 22–65 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Male subjects between 22 and 65 years of age 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. Subject is willing to provide written informed consent and comply with study required follow-up assessments 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): 1. total sperm ≥39 million 2. sperm concentration ≥15 million/mL 3. tot…
Interventions
- Combination ProductOptilume 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.
Locations (9)
- Arkansas UrologyLittle Rock, Arkansas
- Orlando HealthOrlando, Florida
- Florida UrologyTampa, Florida
- Regional UrologyShreveport, Louisiana
- ChesapeakeHanover, Maryland
- Freedman UrologyLas Vegas, Nevada