Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System
2 other identifiers
interventional
120
1 country
1
Brief Summary
The goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE participants to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.
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 Apr 2016
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
First Submitted
Initial submission to the registry
April 14, 2016
CompletedStudy Start
First participant enrolled
April 15, 2016
CompletedFirst Posted
Study publicly available on registry
October 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
October 22, 2025
October 1, 2025
10.6 years
April 14, 2016
October 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of quality and performance of Compact Imaging System (CIS)
Images obtained from the CIS will be assessed for quality and compared to images acquired from the previous imaging system
5-7 Minutes of imaging
Study Arms (1)
OFDI Imaging
EXPERIMENTALExperimental OFDI Imaging
Interventions
Imaging of the esophagus with a compact OFDI system and distal scanning catheter
Eligibility Criteria
You may qualify if:
- Participants 18 years and older with a previous diagnosis of GERD
- Health participants over the age of 18 but less than 85 years of age
- Participants must be able to give informed consent
- Participants must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
You may not qualify if:
- Participants over 85 years of age
- Participants with the inability to swallow pills and capsules.
- Participants with a strong gag reflex
- Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
- Participants who are pregnant. In case of women of child bearing age, we will ask them if they are pregnant and if unsure; ask them to take a pregnancy test.
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
Central Study Contacts
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
- Professor of Pathology
Study Record Dates
First Submitted
April 14, 2016
First Posted
October 28, 2016
Study Start
April 15, 2016
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2028
Last Updated
October 22, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share