- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00751998
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
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
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Brussels, Belgium, 1070
- Erasme Hospital - Belgium
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Kobenhavn NV, Denmark, 2400
- Bispebjerg Hospital, Denmark
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Lyon, Cedex 03, France, 69437
- Hôpital Edouard Herriot
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Dusseldorf, Germany, D-40217
- Evangelisches Krankenhaus Düsseldorf
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Roma, Italy, 00161
- Policlinico Agostino Gemelli
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California
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San Francisco, California, United States, 94120
- California Pacific Medical Center
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital
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Indiana
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Indianapolis, Indiana, United States, 46202-5253
- Indiana University Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Minnesota
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Rochester, Minnesota, United States, 55905-0001
- Mayo Clinic
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Pittsburgh, Pennsylvania, United States, 15123
- University of Pittsburgh
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South Carolina
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Charleston, South Carolina, United States, 29425-0001
- Medical University of South Carolina
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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 |
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Arm 1
Test of SpyGlass device
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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During Procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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Instituto Ecuatoriano de Enfermedades DigestivasCompleted
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