Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule
2 other identifiers
interventional
130
1 country
1
Brief Summary
The purpose of this research is to test the feasibility, sensitivity, and specificity of the marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus (BE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
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
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 25, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
October 22, 2025
October 1, 2025
13.5 years
July 25, 2014
October 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of the marking OFDI capsule for diagnosing BE by comparing OFDI images and biopsy diagnosis
The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.
It is expected that the total experimental time including swallowing the OFDI capsule OFDI, OFDI imaging, and removal of the OFDI capsule will take approximately 20 minutes
Secondary Outcomes (1)
Sensitivity of the marking OFDI Capsule to correctly detect and mark the region of interest in BE
It is expected that the total experimental time including swallowing the OFDI capsule OFDI, marking the region of interest, OFDI imaging, and removal of the OFDI capsule will take approximately 20 minutes
Study Arms (1)
OFDI Capsule Marking and Imaging
EXPERIMENTALParticipant will swallow the OFDI capsule, marking will be performed by making superficial cautery marks on the tissue. This will be followed by imaging using the OFDI Imaging system.
Interventions
Marking and imaging of the esophagus using the OFDI Capsule and system.
Eligibility Criteria
You may qualify if:
- Patients must be undergoing an EGD.
- Patients must be over the age of 18.
- Patients must be able to give informed consent.
You may not qualify if:
- Patients who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure.
- OR patients with a history of hemostasis disorders.
- OR patients with esophageal strictures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Massachusetts General hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guillermo Tearney, MD, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 25, 2014
First Posted
April 21, 2015
Study Start
June 1, 2014
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2029
Last Updated
October 22, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share