Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

Healthy Clinical Trial

Official title:

Pilot Study for Imaging of the Duodenum Using an OFDI Capsule

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02202681
• Other study ID #: 2013-P001405
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 16, 2013
• Est. completion date: July 2028

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 108
• Est. completion date: July 2028
• Est. primary completion date: October 28, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Celiac Disease
• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours.
Primary	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.	Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours