Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

Pilot Study for Imaging of the Duodenum Using an 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy; Celiac Disease
• Intervention / Treatment: Device: OFDI Capsule

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OFDI Capsule Imaging; Participant will swallow the OFDI Capsule and imaging will be performed using the OFDI system.	Device: OFDI Capsule; Imaging of the duodenum with the OFDI capsule and system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of OFDI Imaging in subjects swallowing the OFDI capsule	An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed.	Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours
Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule	After participating in the study, the participant will be asked for feedback about tolerability of the procedure using a questionnaire.	Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Guillermo Tearney, MD., PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2013
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: June 12, 2014
• First Submitted That Met QC Criteria: July 25, 2014
• First Posted (Estimated): July 29, 2014

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Imaging; Optical Coherence Tomography; Celiac Disease; Duodenum; Optical Frequency Domain Imaging (OFDI)
• Additional Relevant MeSH Terms: Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Nutritional and Metabolic Diseases; Celiac Disease
• Other Study ID Numbers: 2013-P001405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No