This trial is active, not recruiting.

Condition healthy
Treatment mgh oct imaging capsule
Sponsor Massachusetts General Hospital
Start date August 2014
End date September 2017
Trial size 20 participants
Trial identifier NCT02445027, 2014-P001519


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose screening
Subject will swallow the OCT capsule and images will be acquired using the OCT Imaging system.
mgh oct imaging capsule
Imaging of the esophagus using the OCT Capsule and system.

Primary Outcomes

Feasibility of OCT Imaging in subjects swallowing the OCT capsule in the primary care setting
time frame: Approximate 20min visit (5min image acquisition)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting
Principal investigator Guillermo Tearney, MD., PhD
Description 20 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.