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


Phase 4
18 Years
N/A
Not Enrolling
Both
Biliary Tract Diseases

Thank you

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 FoundationCleveland, Ohio  44195
Mayo ClinicRochester, Minnesota  55905
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
University of PittsburghPittsburgh, Pennsylvania  15261
University of Colorado HospitalDenver, Colorado  80262
California Pacific Medical CenterSan Francisco, California  94115
Indiana University Medical CenterIndianapolis, Indiana  46202
Columbia University Medical CenterNew York, New York  10032