Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Conditions

• Urethral Stricture

Eligibility Criteria

Sex

MALE

Age

22 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Optilume Urethral DCB — COMBINATION_PRODUCT
  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.

Study Details

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

Key Dates

Start date

Feb 14, 2022

Status verified

Apr 2026

Primary completion

Jun 30, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

34 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Primary Safety Endpoint [ Time Frame: 3-months ]

Central Contacts

• Brenda Johnson, MS
  [email protected]
• Reem Ennenga
  612-747-4183
  [email protected]

Locations (9)

Find similar trials in Little Rock, AR

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