Spy II Clinical Registry

July 28, 2021 updated by: Boston Scientific Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

297

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Erasme Hospital - Belgium
  • Denmark
      • Kobenhavn NV, Denmark, 2400
        • Bispebjerg Hospital, Denmark
  • France
      • Lyon, Cedex 03, France, 69437
        • Hôpital Edouard Herriot
  • Germany
      • Dusseldorf, Germany, D-40217
        • Evangelisches Krankenhaus Düsseldorf
  • Italy
      • Roma, Italy, 00161
        • Policlinico Agostino Gemelli
  • United States
    • California
      • San Francisco, California, United States, 94120
        • California Pacific Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5253
        • Indiana University Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15123
        • University of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29425-0001
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects who are undergoing ERCP or ERCP/cholangioscopy for known or suspected pancreaticobiliary disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm 1
Test of SpyGlass device
Device: SpyGlass
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
During Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Joyce Peetermans, PhD, Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 11, 2008

First Posted (Estimate)

September 12, 2008

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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