RECRUITINGINTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
- Participants must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DEVICE
Experimental OFDI Imaging
Imaging of the esophagus with a compact OFDI system and distal scanning catheter
Locations (1)
Massachusetts General hospital
Boston, Massachusetts, United States