Clinical trial NCT00751998: Spy II Clinical Registry
Official title: A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Tract Diseases
Keywords: biliary
ERCP
cholangioscopy
pancreatic
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-09-12
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who are undergoing ERCP or ERCP/cholangioscopy for known or suspected pancreaticobiliary disease.

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 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

Primary outcomes:
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.
timeFrame: During Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Brussels
country: Belgium
facility: Erasme Hospital - Belgium
city: Kobenhavn NV
country: Denmark
facility: Bispebjerg Hospital, Denmark
city: Lyon, Cedex 03
country: France
facility: Hopital Edouard Herriot
city: Dusseldorf
country: Germany
facility: Evangelisches Krankenhaus Dusseldorf
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
Study officials:
affiliation: Boston Scientific Corporation
name: Joyce Peetermans, PhD
role: STUDY_DIRECTOR
References: