OFDI Imaging for Duodenal Inspection

Palo Alto (17 mi)

Overseen byGuillermo Tearney, MD., PhD

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals over 16 with Celiac disease and healthy volunteers over 18, who can swallow pills and give informed consent. It's not for those with Crohn's, fistulas, strictures smaller than the capsule, or pregnant women.

Inclusion Criteria

I am over 18 years old.

I am over 16 years old and have Celiac disease.

Exclusion Criteria

I cannot swallow pills or capsules.

I have a history of Crohn's disease affecting my intestines.

I am currently pregnant.

I have a narrowing in my esophagus or intestines that is too small for certain medical capsules.

I have an abnormal connection between my esophagus and intestine.

Treatment Details

The study tests a tethered Optical Frequency Domain Imaging (OFDI) capsule to see if it can comfortably and effectively take pictures of the duodenum as it moves through the esophagus into the stomach.

1Treatment groups

Experimental Treatment

Group I: OFDI Capsule ImagingExperimental Treatment1 Intervention

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