Spy II Clinical Registry

Completed

• Conditions: Biliary Tract Diseases
• Interventions: Device: SpyGlass

• Registration Number: NCT00751998
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2008-04
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-12
• Study Completion: 2009-10
• Results First Submitted: 2011-03-16
• Results First Submitted QC: 2011-03-16
• Results First Posted: 2011-04-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 297

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1	SpyGlass	Test of SpyGlass device

Primary Outcome Measures

Name	Time	Method
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.	During Procedure

Trial Locations

Locations (15)

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Hopital Edouard Herriot; 🇫🇷 Lyon, Cedex 03, France

Evangelisches Krankenhaus Dusseldorf; 🇩🇪 Dusseldorf, Germany

Policlinico Agostino Gemelli; 🇮🇹 Roma, Italy

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Indiana University Medical Center; 🇺🇸 Indianapolis, Indiana, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Bispebjerg Hospital, Denmark; 🇩🇰 Kobenhavn NV, Denmark

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Erasme Hospital - Belgium; 🇧🇪 Brussels, Belgium