Status: Recruiting

Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study

The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.

Participants needed: 92

Trial details

Age: 50+Biological sex: MaleType: InterventionalSponsor: Urotronic Inc.Updated: Jul 10, 2026Locations: 7

Eligibility criteria

Male subject ≥ 50 years old [+6]

Unwilling to abstain from sexual intercourse or use a condom for 30 days post-pr... [+13]

Status: Recruiting

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

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

Participants needed: 34

Trial details

Phase: Phase 4Age: 22-65Biological sex: MaleType: InterventionalSponsor: Urotronic Inc.Updated: Apr 28, 2026Locations: 9

Eligibility criteria

Male subjects between 22 and 65 years of age [+7]

Subjects with a known hypersensitivity to paclitaxel or structurally related com... [+5]

Status: Recruiting

The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures.

Participants needed: 60

Trial details

Age: 18+Biological sex: AllType: InterventionalSponsor: Urotronic Inc.Updated: Mar 9, 2026Locations: 7

Eligibility criteria

Age 18 years or older [+2]

Treatment of the target ureter with incision or balloon dilation within 3 months... [+26]