Spy II Clinical Registry

N/ACompletedNCT00751998

Boston Scientific Corporation297 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

297

Conditions

Biliary Tract Diseases

Interventions

SpyGlassDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

California Pacific Medical Center

San Francisco, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Outcomes

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

Data from ClinicalTrials.gov

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