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Enrolling by invitation NCT02202681

Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

No phase Interventional Celiac Disease Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OFDI Capsule.
Who it may be relevant to
Registry conditions: Celiac Disease, Healthy. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Pilot Study for Imaging of the Duodenum Using an OFDI Capsule

Overview

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.

Detailed description

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.

Interventions

  • Device OFDI Capsule
    Imaging of the duodenum with the OFDI capsule and system

Primary outcome measures

  • 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.]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT02202681 · 2013-P001405

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗