Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

Mass General Brigham

Status

Invitation-only

Conditions

Healthy

Celiac Disease

Treatments

Device: OFDI Capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT02202681

2013-P001405

Details and patient eligibility

About

The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule to image the duodenum.

A total of 108 participants (36 healthy and 72 with clinically suspected or diagnosed Celiac disease) will be asked to swallow the tethered capsule, while they are awake and unsedated and ask for their feedback. Images will be taken using the OFDI system while the capsule travels from the esophagus into the stomach and into the duodenum.

Full description

Participants including healthy volunteers as well as patients with Celiac disease will be recruited and asked to swallow the OFDI 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, through the stomach and into the duodenum using natural propulsive force called peristalsis.

As the capsule progresses, multiple 2-dimensional cross-sectional images of the duodenum are acquired. Images are analyzed at a later stage.

Enrollment

108 estimated patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participant must be over 18 years for healthy volunteers
Participants must be over 16 years for patients with Celiac disease
Participant must be able to give informed consent

Exclusion criteria

Participants with an inability to swallow pills or capsules.
Participants with esophageal or intestinal fistulas.
Participants with known esophageal or intestinal strictures resulting in a luminal diameter smaller than the diameter of the capsule.
Participants with a history of intestinal Crohn's disease.
Women who are pregnant.