NCT03205072

POCS in Liver Transplantation Patients

Per-Oral Cholangioscopy in Liver Transplantation Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multi-center, non-randomized, observational, consecutive case series, which will compare Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) and cholangioscopy with Spy Glass Digital System (DS) procedure at 5-10 centers.

Detailed description

The objective of this study is to demonstrate the clinical utility of cholangioscopy with Spy Glass Digital System (DS) in cadaveric donor or live donor liver transplantation patients who are referred for ERCP in the setting of a clinical suspicion of post liver transplant bile duct stricture(s). A secondary study objective is to generate a hypothesis for a randomized controlled trial comparing ERCP alone to ERCP with Per- Oral Cholangioscopy (POCS) in patients referred for ERCP post liver transplantation.

Conditions

• Liver Transplant; Complications

Interventions

Type	Name	Description
DEVICE	Spy Glass DS	The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.

Timeline

• Start date: 2018-01-25
• Primary completion: 2022-03-24
• Completion: 2022-03-24
• First posted: 2017-07-02
• Last updated: 2022-07-28

Locations

5 sites across 4 countries: United States, Brazil, Netherlands, Spain

Regulatory

• FDA-regulated device study