Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

Not Applicable

• Conditions: Celiac Disease; Healthy
• Interventions: Device: OFDI Capsule

• Registration Number: NCT02202681
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-09-16
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-07-25
• Study First Posted: 2014-07-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Primary Completion: 2026-10-28
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OFDI Capsule Imaging	OFDI Capsule	Subject will swallow the OFDI Capsule and imaging will be performed using the OFDI system.

Primary Outcome Measures

Name	Time	Method
Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule	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.
Feasibility of OFDI Imaging in subjects swallowing the OFDI capsule	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States