Pilot Study for Imaging of the Esophagus Using Tethered Capsule OCT Endomicroscopy With Distal Scanning

Mass General Brigham

Status: Completed

Conditions: Healthy

Treatments: Device: OFDI capsule

Study type: Observational

Funder types: Other

Identifiers

NCT02947997

2015-P000777

Details and patient eligibility

About

The purpose of this study is to test feasibility of a redesigned tethered capsule catheter that contains an integrated micro-motor. Investigators will be testing imaging of this new technology in healthy volunteers.

Full description

10 healthy volunteers will be enrolled and asked to swallow the Distal Scanning Capsule. The subjects will be awake and un-sedated.

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 natural propulsive force called peristalsis.

As the capsule progresses through the esophagus, multiple images of the esophagus are acquired in real time to be analyzed later.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 the inability to swallow pills and capsules.
• Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
• Subjects who have a bleeding disorder and are currently on anti-coagulants.

Trial design

4 participants in 1 patient group

OFDI capsule imaging

Description:

Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.

Treatment:

Device: OFDI capsule