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Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

NCT03423979 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-11-26

Study results available
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Summary

A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years.

The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.

Conditions

  • Benign Prostatic Hyperplasia
  • Benign Prostatic Hypertrophy

Interventions

DEVICE

Optilume™ BPH Prostatic DCB Dilation Catheter

BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).

DRUG

Paclitaxel

paclitaxel will release to adjacent tissue after the balloon inflated in the urethra

Sponsors & Collaborators

  • Urotronic Inc.

    lead INDUSTRY

Principal Investigators

  • Jill Moland · Urotronic Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-19
Primary Completion
2019-06-04
Completion
2024-05-25
FDA Device
Yes

Countries

  • Dominican Republic
  • Panama

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03423979 on ClinicalTrials.gov