EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures
ConditionUreteral Stricture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUrotronic Inc.
About this trial
The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Optilume
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Urotronic Inc.
Lead sponsor
Laborie Medical Technologies Inc.
Collaborator
Source ClinicalTrials.gov