se of SpyGlass Discover Digital System during a percutaneous transhepatic cholangiopancreatoscopy procedure.
Phase 4
- Conditions
- Health Condition 1: K00-K95- Diseases of the digestive system
- Registration Number
- CTRI/2021/11/037874
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Scheduled for a percutaneous transhepatic procedure to access the pancreaticobiliary anatomy that will accommodate passage of SpyGlassââ??¢ Discover Digital Catheter per local standard of practice
2.Written informed consent from patient or legally authorized representative of the patient
Exclusion Criteria
1. Contraindication for cholangiopancreatoscopy
2. Subjects with unresolved adverse event(s) associated with prior percutaneous pancreaticobiliary ductal access
3. <18 years of age
4. Potentially vulnerable subjects, including, but not limited to pregnant women
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is achieving the clinical intent of the procedure by 30 days (�±3 days) after index PTCSTimepoint: 30 days
- Secondary Outcome Measures
Name Time Method