Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT02202681

Collaborator

(none)

Enrollment

Location

Arm

105.5

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Celiac Disease Healthy	Device: OFDI Capsule	N/A

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

Study Type:

Interventional

Anticipated 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

Actual Study Start Date :

Sep 16, 2013

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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

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

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.