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 subjects 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 18 Years and 70 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- A previous diagnosis of BE (not an inclusion criteria for healthy volunteers) - Subjects must be over the age of 18 but less than 70 year of age. - Subjects must be able to give informed consent - Subjects 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
- Subjects over 70 years of age - Subjects with the inability to swallow pills and capsules. - Subjects with a strong gag reflex - Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule. - Pregnancy. If the subject is unsure, she will be asked 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, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed Description
Ten healthy volunteer subjects and ten volunteers 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.