A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Biliary Tract Diseases
Both
Biliary Tract Diseases
Trial Information
A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
During Procedure
Safety Issue:
No
Principal Investigator
Joyce Peetermans, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Boston Scientific Corporation
Authority:
United States: Institutional Review Board
Study ID:
E7012
NCT ID:
NCT00751998
Start Date:
November 2006
Completion Date:
October 2009
Related Keywords:
- Biliary Tract Diseases
- biliary
- ERCP
- cholangioscopy
- pancreatic
- Biliary Tract Diseases
Name | Location |
|---|---|
| Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
| Mayo Clinic | Rochester, Minnesota 55905 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
| University of Colorado Hospital | Denver, Colorado 80262 |
| California Pacific Medical Center | San Francisco, California 94115 |
| Indiana University Medical Center | Indianapolis, Indiana 46202 |
| Columbia University Medical Center | New York, New York 10032 |
