Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-16

Study Completion Date

2028-07-31

Brief Summary

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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.

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Detailed Description

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Participants 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.

Conditions

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Celiac Disease Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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OFDI Capsule Imaging

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

Group Type EXPERIMENTAL

OFDI Capsule

Intervention Type DEVICE

Imaging of the duodenum with the OFDI capsule and system

Interventions

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OFDI Capsule

Imaging of the duodenum with the OFDI capsule and system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes