Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging
Pilot Study to Evaluate Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging
1 other identifier
interventional
7
1 country
1
Brief Summary
The goal of this study is to evaluate the potential of comprehensive biliary Optical Frequency Domain Imaging (OFDI) for assessing common bile duct or common hepatic duct strictures, determining cholangiocarcinoma margins, and evaluating primary sclerosing cholangitis (PSC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2010
CompletedFirst Submitted
Initial submission to the registry
September 20, 2011
CompletedFirst Posted
Study publicly available on registry
September 23, 2011
CompletedResults Posted
Study results publicly available
September 19, 2018
CompletedApril 10, 2019
March 1, 2019
6 months
September 20, 2011
July 24, 2018
March 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of Imaging the Bile Duct With the OFDI Probe
The number of subjects in which the performed OFDI imaging visualizes common bile duct and common hepatic duct strictures.
day 1, during diagnostic procedure
Study Arms (1)
OFDI imaging
EXPERIMENTALSubject will swallow an OFDI capsule and images will be obtained using MGH Optical Frequency Domain Imaging (OFDI) imaging system.
Interventions
Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System
Eligibility Criteria
You may qualify if:
- Patient age ≥18 and up to 75 years old
- Patients able to give informed consent
- Patients with bile duct measuring ≥4 mm in diameter
- Patients with established biliary enteric access - specifically, a previously performed biliary sphincterotomy, or a biliary sphincterotomy performed during the current ERCP for indications other than participation in the study
- Women of childbearing potential must have a negative urine pregnancy test obtained prior to the procedure
You may not qualify if:
- Patients with pancreatitis
- Pregnant women
- Patients on oral anticoagulant (warfarin) therapy
- Patients with known history of hemostatic disorder
- Patients found to have a biliary fistula on diagnostic ERCP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Results Point of Contact
- Title
- Gary Tearney, MD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Guillermo Tearney, MD PhD
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
David Forcione, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pathology
Study Record Dates
First Submitted
September 20, 2011
First Posted
September 23, 2011
Study Start
February 1, 2009
Primary Completion
July 20, 2009
Study Completion
July 20, 2010
Last Updated
April 10, 2019
Results First Posted
September 19, 2018
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share