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Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

NCT02202681 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-10-22

No results posted yet for this 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.

Conditions

Interventions

DEVICE

OFDI Capsule

Imaging of the duodenum with the OFDI capsule and system

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Guillermo Tearney, MD., PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-16
Primary Completion
2026-10-28
Completion
2028-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02202681 on ClinicalTrials.gov