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Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

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ClinicalTrials.gov Identifier: NCT02202681
Recruitment Status : Recruiting
First Posted : July 29, 2014
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital

Study Description
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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.

Study Design
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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
Study Start Date : August 2013
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02202681


Contacts
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Contact: Anna Gao, RN 617-643-6092 Tearneylabtrials@partners.org
Contact: Anita Chung, RN 617-724-4515 Tearneylabtrials@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Anna Gao, RN    617-643-6092    Tearneylabtrials@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Guillermo Tearney, MD., PhD Massachusetts General Hospital
More Information
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Responsible Party: Guillermo Tearney, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02202681    
Other Study ID Numbers: 2013-P001405
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
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:
Duodenum
Optical Frequency Domain Imaging (OFDI)
Optical Coherence Tomography
Imaging
Celiac Disease
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases