Spy II Clinical Registry

A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.

Completed

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Key information

Conditions

Biliary Tract Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasme Hospital - Belgium, Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female >= 18 years of age
Willing and able to comply with the Registry procedures and provide written informed consent to participate in the Registry
Indicated for ERCP or ERCP/cholangioscopy (with or without biopsy)

Exclusion criteria

Subjects for whom endoscopic procedure are medically contraindicated
Subjects for whom ERCP are medically contraindicated
Subjects for whom medical condition warrants use of device outside of indication for use

Treatment and study plan

SpyGlass

Device

The SpyGlass Direct Visualization System is an integrated product platform that is designed to provide a direct intraluminal view of the biliary duct system and direct therapeutic devices.

Primary outcomes

Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal.

Time frame: During Procedure

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2009
First posted: Sep 12, 2008
Registry last updated: Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed