OFDI Imaging for Duodenal Inspection

N/A

Waitlist Available

Led By Guillermo Tearney, MD., PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must be over 18 years for healthy volunteers

Subjects must be over 16 years for patients with Celiac disease

Must not have

Subjects with an inability to swallow pills or capsules

Subjects with a history of intestinal Crohn's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up images will be acquired during the ofdi imaging session which should on average take anywhere from 30 minutes to 2 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is being done to see if a tethered capsule, which takes pictures, is tolerable and feasible to use to image the duodenum.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from swallowing the capsule or minor throat irritation. Since participants are unsedated, sedation risks are avoided.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I am over 16 years old and have Celiac disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot swallow pills or capsules.

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

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I am currently pregnant.

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

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I have an abnormal connection between my esophagus and intestine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ images will be acquired during the ofdi imaging session which should on average take anywhere from 30 minutes to 2 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~images will be acquired during the ofdi imaging session which should on average take anywhere from 30 minutes to 2 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and images will be acquired during the ofdi imaging session which should on average take anywhere from 30 minutes to 2 hours for reporting.