SpyGlass Surgical Study
NCT05822635 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 34
Last updated 2025-01-08
Summary
* To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
* To identify specific surgical procedures in which intraoperative use of a thin, single use, flexible cholangiopancreatoscope suggests clinically meaningful benefit and generate a hypothesis for possible subsequent claims-supportive study
Conditions
- Pancreatic Diseases
- Bile Duct Diseases
- Hepatic Disease
Interventions
- DEVICE
-
SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System
Observational, prospective study for the clinical utility of the SpyGlass Discover Digital Catheter and the SpyScope DS Catheter during an intraoperative endoscopy procedure.
Sponsors & Collaborators
-
Boston Scientific Corporation
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-01
- Primary Completion
- 2024-12-04
- Completion
- 2025-01-03
- FDA Device
- Yes
Countries
- United States
- China
- Hong Kong
- India
Study Locations
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