Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

Last updated: October 20, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Enrolling

Phase

N/A

Condition

Celiac Disease

Treatment

OFDI Capsule

Clinical Study ID

NCT02202681
2013-P001405
  • Ages > 16
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 luminaldiameter smaller than the diameter of the capsule.

  • Participants with a history of intestinal Crohn's disease.

  • Women who are pregnant.

Study Design

Total Participants: 108
Treatment Group(s): 1
Primary Treatment: OFDI Capsule
Phase:
Study Start date:
September 16, 2013
Estimated Completion Date:
July 31, 2028

Study 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.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

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