Optilume Treatment for Urethral Stricture
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Recruiting
Phase 4
Interventional Study
Urethral Stricture
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 22 – 65
- Sex
- Male
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 34 (estimated)
- Sponsor
- Urotronic Inc. · Industry
Who this trial is looking for
This trial is looking for men aged 22 to 65 with a specific urethra condition. Participants will receive treatment and provide semen samples to assess their quality after the procedure.
Are You a Good Fit for This Trial?
You may be able to join if
- I am a male between 22 and 65 years old
- I have been diagnosed with a stricture in my anterior urethra
- I can give written consent and follow up as needed
- I can provide viable semen samples
- My average semen quality is above reference values
You may not be able to join if
- I am allergic to paclitaxel or related compounds
- I have had a vasectomy or conditions affecting semen production
- I am taking certain medications without proper washout
- I cannot abstain or use a condom for 30 days after the procedure
- I cannot use effective contraception for 6 months if my partner can become pregnant
- I have a history of cancer that is not in complete remission
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
Trial Locations
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Eligibility Criteria
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 …
Contacts