Direct visualization and treatment of pancreatico-biliary system with a single-use cholangiopancreatoscope during a pancreatico-biliary surgical procedure.
Phase 3
- Conditions
- Health Condition 1: K80-K87- Disorders of gallbladder, biliary tract and pancreasHealth Condition 2: K80-K87- Disorders of gallbladder, biliary tract and pancreas
- Registration Number
- CTRI/2023/12/060728
- Lead Sponsor
- Boston Scientific India Private Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Clinical indication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
Written informed consent from patient or legally authorized representative of the patient
Exclusion Criteria
Contraindication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
Potentially vulnerable subjects, including, but not limited to pregnant women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Technical success: Perform intraoperative endoscopy as intended using a thin, single-use, flexible cholangiopancreatoscope as desired, including but not limited to: <br/ ><br>• Direct visualization of target lesion or stricture <br/ ><br>• Obtaining biopsies <br/ ><br>• Initiating and/or completing stone clearanceTimepoint: At time of the procedure
- Secondary Outcome Measures
Name Time Method