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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Optilume
DeviceHas pre-treatment (balloon dilation or ureterotomy) followed by paclitaxel-coated balloon (Optilume) treatment of the ureteric stricture.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: OptilumeExperimental treatment 1 intervention
Trial outcomes
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
Time frame
6-months post ureteral stent removal (approximately 7 months post Optilume treatment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Urotronic Inc.
Lead sponsor
Laborie Medical Technologies Inc.
Collaborator
Source ClinicalTrials.gov