EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures
Urotronic Inc.
Summary
The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 years or older 2. Single lesion ureteric or uretero-enteric stricture less than or equal to 4.0 cm in length 3. Two functioning kidneys Exclusion Criteria: 1. Treatment of the target ureter with incision or balloon dilation within 3 months of the study treatment 2. Subjects with more than one ureteric stricture 3. Subjects with target stricture in bifid or duplicated ureter 4. Known sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel 5. Ureteric stricture caused by extrinsic compression of the ureter 6. Unable to endosc…