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Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02202681
Recruitment Status : Enrolling by invitation
First Posted : July 29, 2014
Last Update Posted : July 22, 2021
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital

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 24 subjects 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.

Condition or disease Intervention/treatment Phase
Celiac Disease Healthy Device: OFDI Capsule Not Applicable

Detailed Description:

Subjects 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Study for Imaging of the Duodenum Using an OFDI Capsule
Actual Study Start Date : September 16, 2013
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: OFDI Capsule Imaging
Subject 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

Primary Outcome Measures :
  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 subject 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subject must be over 18 years for healthy volunteers
  • Subjects must be over 16 years for patients with Celiac disease
  • Subject must be able to give informed consent

Exclusion Criteria:

  • Subjects with an inability to swallow pills or capsules.
  • Subjects with esophageal or intestinal fistulas.
  • Subjects with known esophageal or intestinal strictures resulting in a luminal diameter smaller than the diameter of the capsule.
  • Subjects with a history of intestinal Crohn's disease.
  • Women who are pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02202681

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Guillermo Tearney, MD., PhD Massachusetts General Hospital
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Responsible Party: Guillermo Tearney, Principal Investigator, Massachusetts General Hospital Identifier: NCT02202681    
Other Study ID Numbers: 2013-P001405
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
Optical Frequency Domain Imaging (OFDI)
Optical Coherence Tomography
Celiac Disease
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases