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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.
ClinicalTrials.gov Identifier: NCT00751998
Recruitment Status : Completed
First Posted : September 12, 2008
Results First Posted : April 12, 2011
Last Update Posted : February 11, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
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
Primary Completion Date : April 2008
Study Completion Date : October 2009
Arms and Interventions

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.


Outcome Measures

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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00751998


Locations
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
Belgium
Erasme Hospital - Belgium
Brussels, Belgium, 1070
Denmark
Bispebjerg Hospital, Denmark
Kobenhavn NV, Denmark, 2400
France
Hopital Edouard Herriot
Lyon, Cedex 03, France, 69437
Germany
Evangelisches Krankenhaus Dusseldorf
Dusseldorf, Germany, D-40217
Italy
Policlinico Agostino Gemelli
Roma, Italy, 00161
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Joyce Peetermans, PhD Boston Scientific Corporation
More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00751998     History of Changes
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:
biliary
ERCP
cholangioscopy
pancreatic

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases