COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Spy II Clinical Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00751998
Recruitment Status : Completed
First Posted : September 12, 2008
Results First Posted : April 12, 2011
Last Update Posted : February 11, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Biliary Tract Diseases Device: SpyGlass Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System
Study Start Date : November 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: 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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Diagnosis. [ Time Frame: Procedural through end of study ]
  2. Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Subject Management. [ Time Frame: Procedure or at 12 months ]
  3. Ability to Visualize and Access Various Targeted Anatomic Areas. [ Time Frame: Procedure ]
  4. Sensitivity of SpyBite Biopsy Forceps in Malignant Strictures. [ Time Frame: Post Procedure ]
  5. Safety [ Time Frame: Procedural through end of study ]
  6. Device Durability and Device Performance. [ Time Frame: Procedure ]
  7. Health Resources Utilization (Health Economics) [ Time Frame: Procedure through end of study. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00751998

Layout table for location information
United States, California
California Pacific Medical Center
San Francisco, California, United States, 94120
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202-5253
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905-0001
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15123
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0001
Erasme Hospital - Belgium
Brussels, Belgium, 1070
Bispebjerg Hospital, Denmark
Kobenhavn NV, Denmark, 2400
Hopital Edouard Herriot
Lyon, Cedex 03, France, 69437
Evangelisches Krankenhaus Dusseldorf
Dusseldorf, Germany, D-40217
Policlinico Agostino Gemelli
Roma, Italy, 00161
Sponsors and Collaborators
Boston Scientific Corporation
Layout table for investigator information
Study Director: Joyce Peetermans, PhD Boston Scientific Corporation
Layout table for additonal information
Responsible Party: Boston Scientific Corporation Identifier: NCT00751998    
Other Study ID Numbers: E7012
First Posted: September 12, 2008    Key Record Dates
Results First Posted: April 12, 2011
Last Update Posted: February 11, 2013
Last Verified: February 2013
Keywords provided by Boston Scientific Corporation:
Additional relevant MeSH terms:
Layout table for MeSH terms
Biliary Tract Diseases
Digestive System Diseases