Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
ConditionUrethral Stricture
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age22-65
SponsorUrotronic Inc.
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.
Eligibility criteria
Qualifiers
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
total sperm ≥39 million
Disqualifiers
Subjects with a known hypersensitivity to paclitaxel or structurally related compounds
Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function
Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout
Subject is unwilling to abstain or utilize a condom for 30 days after the procedure
Trial design
Treatments tested in this trial
- Optilume Urethral DCB
Treatment groups
34 Participants
are divided into 1 treatment groupSponsors and collaborators
Urotronic Inc.
Lead sponsor
Laborie Medical Technologies Inc.
Collaborator
Source ClinicalTrials.gov