RecruitingNot Applicable

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

United States60 participantsStarted 2025-10-01

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Successful treatment

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

NCT IDNCT07020520

SponsorUrotronic Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-28

Steven M Principal Clinical Project Manager