Status:

COMPLETED

Spy II Clinical Registry

Lead Sponsor:

Boston Scientific Corporation

Conditions:

Biliary Tract Diseases

Eligibility:

All Genders

18+ years

Brief Summary

A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2006

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 1 2009

Estimated Enrollment :

297 Patients enrolled

Trial Details

Trial ID

NCT00751998

Start Date

November 1 2006

End Date

October 1 2009

Last Update

August 19 2021

Active Locations (15)

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Page 1 of 4 (15 locations)

1

California Pacific Medical Center

San Francisco, California, United States, 94120

2

University of Colorado Hospital

Aurora, Colorado, United States, 80045

3

Indiana University Medical Center

Indianapolis, Indiana, United States, 46202-5253

4

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215