Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting

Massachusetts General Hospital60 enrolled

Overview

The goal of this study is to test the feasibility and acceptability of tethered capsule Optical Coherence Tomography (OCT) endomicroscopy as a device for population-based screening in the primary care practice environment.

60 healthy volunteers scheduled for a routine primary care visit will be recruited and asked to swallow the OCT capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis. As the capsule progresses through the esophagus, multiple images of the esophagus are acquired and later analyzed.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

MGH OCT Imaging CapsuleDEVICE

Imaging of the esophagus using the OCT Capsule and system.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must be scheduled for non-urgent appointment at primary care practice including annual wellness visits and routine follow-up appointments. * Subjects must be over the age of 18 * 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 with current symptoms of dysphagia * Subjects with any history of intestinal strictures, prior GI surgery, or history of intestinal Crohn's disease. * Subjects with current symptoms of fever, nausea or sore throat at the time of the appointment. * Pregnancy

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting.

Number of Participants able to swallow the capsule successfully. An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. This is a feasibility study and was not used for any diagnosis.

Time frame: Approximate 20min visit (5min image acquisition)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.