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

Mass General Brigham

Status

Completed

Conditions

Healthy

Treatments

Device: MGH OCT Imaging Capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT02445027

2014-P001519

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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