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

NCT07020520 | Recruiting FDA Device

• 1 other identifier: 1391
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

ureteral; ureteric; stricture; stenosis; optilume

Outcome Measures

Primary Outcomes (1)

• Successful treatment

  Rate of successful treatment defined as meeting all the following criteria: * Technical success * Freedom from retreatment of target stricture through six months post stent removal * Renogram at 6 months showing stability or improvement in split function for impacted kidney defined as split function within 10% of baseline value or improved from baseline. * T1/2 stability or improvement from baseline to 6 months for impacted kidney

  6-months post ureteral stent removal (approximately 7 months post Optilume treatment)

Study Arms (1)

Optilume

EXPERIMENTAL

Treatment with Optilume for ureteric stricture

Device: Optilume

Interventions

Optilume DEVICE

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

Optilume

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Single lesion ureteric or uretero-enteric stricture less than or equal to 4.0 cm in length
• Two functioning kidneys

You may not qualify if:

• Treatment of the target ureter with incision or balloon dilation within 3 months of the study treatment
• Subjects with more than one ureteric stricture
• Subjects with target stricture in bifid or duplicated ureter
• Known sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
• Ureteric stricture caused by extrinsic compression of the ureter
• Unable to endoscopically access target stricture for any reason
• Existing stones in the ipsilateral kidney or ureter (except for asymptomatic kidney stones) that are in close proximity to the target ureteric stricture
• Chronic renal failure treated with dialysis
• eGFR \<30 mL/min/1.73m2
• Kidney function ≤ 25% of split function on the side with target stricture as measured by functional renogram
• Kidney function ≤35% of split function on the side opposite target stricture as measured by functional renogram or other significant pathology or impairment that may impact renal function
• Life expectancy less than 12 months
• Women who are pregnant or breastfeeding
• Women of child-bearing potential planning to get pregnant in the next year or are unwilling to use contraception over the next 12 months
• Males unwilling to abstain or use protected sex for 30 days post treatment

Sponsors & Collaborators

• Urotronic Inc.: lead
• Laborie Medical Technologies Inc.: collaborator

Study Sites (7)

University of California Irvine

Orange, California, 92868, United States

RECRUITING

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Mount Sinai

New York, New York, 10003, United States

RECRUITING

NYU Langone

New York, New York, 10016, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jamie Landman, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven M Principal Clinical Project Manager

CONTACT

952-426-6079; smadej@laborie.com

Reem Ennenga

CONTACT

rennenga@laborie.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There is a main study and pharmacokinetic (PK) substudy. All subjects will receive the same treatment. PK substudy subjects (15) will also have serum and urine samples collected for analysis of paclitaxel levels.

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 13, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): July 30, 2031
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)