NCT00751998

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2006

Typical duration for all trials

Geographic Reach
6 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 12, 2011

Completed
Last Updated

August 19, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

September 11, 2008

Results QC Date

March 16, 2011

Last Update Submit

July 28, 2021

Conditions

Biliary Tract Diseases

Keywords

biliaryERCPcholangioscopypancreatic

Outcome Measures

Primary Outcomes (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.

    During Procedure

Study Arms (1)

Arm 1

Test of SpyGlass device

Device: SpyGlass

Interventions

SpyGlassDEVICE

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.

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects who are undergoing ERCP or ERCP/cholangioscopy for known or suspected pancreaticobiliary disease.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

California Pacific Medical Center

San Francisco, California, 94120, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202-5253, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905-0001, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15123, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0001, United States

Location

Erasme Hospital - Belgium

Brussels, 1070, Belgium

Location

Bispebjerg Hospital, Denmark

København NV, 2400, Denmark

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Evangelisches Krankenhaus Dusseldorf

Düsseldorf, D-40217, Germany

Location

Policlinico Agostino Gemelli

Roma, 00161, Italy

Location

MeSH Terms

Conditions

Biliary Tract Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Results Point of Contact

Title
Joyce Peetermans, PhD, Director Endoscopy Clinical
Organization
Boston Scientific Corporation
peetermj@bsci.com
508-683-4211

Study Officials

  • Joyce Peetermans, PhD

    Boston Scientific Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 12, 2008

Study Start

November 1, 2006

Primary Completion

April 1, 2008

Study Completion

October 1, 2009

Last Updated

August 19, 2021

Results First Posted

April 12, 2011

Record last verified: 2021-07

Locations

DE(1)US(10)IT(1)BE(1)DK(1)FR(1)