MedTrace Logo

EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures

NCT07020520 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-09

No results posted yet for this study

Summary

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

Conditions

  • Ureteral Stricture

Interventions

DEVICE

Optilume

Has pre-treatment (balloon dilation or ureterotomy) followed by paclitaxel-coated balloon (Optilume) treatment of the ureteric stricture.

Sponsors & Collaborators

  • Laborie Medical Technologies Inc.

    collaborator INDUSTRY

  • Urotronic Inc.

    lead INDUSTRY

Principal Investigators

  • Jamie Landman, MD · University of California, Irvine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-02-28
Completion
2031-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT07020520 on ClinicalTrials.gov