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

Boston Scientific Corporation15 sites in 6 countries297 target enrollmentNovember 2006

ConditionsBiliary Tract Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Biliary Tract Diseases
Sponsor: Boston Scientific Corporation
Enrollment: 297
Locations: 15
Primary Endpoint: 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.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

October 2009

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

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

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