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Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

Primary Purpose

Celiac Disease, Healthy

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OFDI Capsule
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Celiac Disease focused on measuring Duodenum, Optical Frequency Domain Imaging (OFDI), Optical Coherence Tomography, Imaging, Celiac Disease

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OFDI Capsule Imaging

Arm Description

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

Outcomes

Primary Outcome Measures

Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule
After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire.
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.

Secondary Outcome Measures

Full Information

First Posted
June 12, 2014
Last Updated
January 12, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02202681
Brief Title
Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule
Official Title
Pilot Study for Imaging of the Duodenum Using an OFDI Capsule
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 16, 2013 (Actual)
Primary Completion Date
October 28, 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease, Healthy
Keywords
Duodenum, Optical Frequency Domain Imaging (OFDI), Optical Coherence Tomography, Imaging, Celiac Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OFDI Capsule Imaging
Arm Type
Experimental
Arm Description
Subject will swallow the OFDI Capsule and imaging will be performed using the OFDI system.
Intervention Type
Device
Intervention Name(s)
OFDI Capsule
Intervention Description
Imaging of the duodenum with the OFDI capsule and system
Primary Outcome Measure Information:
Title
Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule
Description
After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire.
Time Frame
Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours.
Title
Feasibility of OFDI Imaging in subjects swallowing the OFDI capsule
Description
An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed.
Time Frame
Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Tearney, MD., PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

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