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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

34 Participants

are divided into 1 treatment group

Group A: Optilume Urethral DCBExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Primary Safety Endpoint

Average Change in Sperm Concentration from baseline to 3-months

Time frame

3-months

Secondary outcomes

Secondary Safety Endpoint

Proportion of Subjects Experiencing ≥50% Decrease in Sperm Concentration from Baseline at 3 and 6 Months

Time frame

6-months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Urotronic Inc.

Lead sponsor

Laborie Medical Technologies Inc.

Collaborator

Source ClinicalTrials.gov

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