Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

NCT02202681 | Enrolling By Invitation

• 1 other identifier: 2013-P001405
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Celiac Disease; Healthy

Keywords

Duodenum; Optical Frequency Domain Imaging (OFDI); Optical Coherence Tomography; Imaging; Celiac Disease

Outcome Measures

Primary Outcomes (2)

• 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.

• 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

Study Arms (1)

OFDI Capsule Imaging

EXPERIMENTAL

Participant will swallow the OFDI Capsule and imaging will be performed using the OFDI system.

Device: OFDI Capsule

Interventions

OFDI Capsule DEVICE

Imaging of the duodenum with the OFDI capsule and system

OFDI Capsule Imaging

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Guillermo Tearney, MD., PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: July 29, 2014
• Study Start: September 16, 2013
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)