NCT03766035

Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard endoscopic retrograde cholangiopancreatography (ERCP) with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing cholangitis (PSC).

Detailed description

The primary objective of this study is to demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard ERCP with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing cholangitis (PSC).

Conditions

• Primary Sclerosing Cholangitis (PSC)

Interventions

Type	Name	Description
DEVICE	SpyGlass DS I - II	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: 2018-12-06
• Primary completion: 2022-12-12
• Completion: 2022-12-12
• First posted: 2018-12-05
• Last updated: 2023-01-25

Locations

6 sites across 4 countries: United States, Canada, Netherlands, Norway

Regulatory

• FDA-regulated device study