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Enrolling by Invitation

NCT Number: NCT02202681

Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Healthy Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OFDI Capsule

Device

Imaging of the duodenum with the OFDI capsule and system

Primary outcomes

  1. Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule

    Time frame: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours.

    After participating in the study, the participant will be asked for feedback about tolerability of the procedure using a questionnaire.

  2. Feasibility of OFDI Imaging in subjects swallowing the OFDI capsule

    Time frame: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours

    An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Pilot Study for Imaging of the Duodenum Using an OFDI Capsule

Important dates

Study start
2013
Primary completion
2026
Study completion
2028
First posted
Jul 29, 2014
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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