Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
Purpose
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.
Condition
- Barrett's Esophagus
Eligibility
- Eligible Ages
- Between 14 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- A previous diagnosis of BE (not an inclusion criteria for healthy volunteers) - Participants 18 years and older with a previous diagnosis of GERD - Participants 14 years and older with a previous diagnosis of EoE (not an inclusion criteria for healthy volunteers) - 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.
Exclusion Criteria
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental OFDI Imaging |
Experimental OFDI Imaging |
|
Recruiting Locations
Massachusetts General hospital
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed Description
Ten healthy participants and ten participants with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled in the study. The capsule is attached to a string-like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using peristalsis. Images of the esophagus will be acquired in real time to be analyzed later.