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Imaging Device

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
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

Study 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.Check my eligibility
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.See study design
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
Select...
I am over 18 years old.
Select...
I am over 16 years old and have Celiac 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
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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of OFDI Imaging in subjects swallowing the OFDI capsule
Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OFDI Capsule
2013
N/A
~70

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,331 Total Patients Enrolled
4 Trials studying Celiac Disease
616 Patients Enrolled for Celiac Disease
Guillermo Tearney, MD., PhDPrincipal InvestigatorMassachusetts General Hospital
5 Previous Clinical Trials
209 Total Patients Enrolled

Media Library

OFDI Capsule (Imaging Device) Clinical Trial Eligibility Overview. Trial Name: NCT02202681 — N/A
Celiac Disease Research Study Groups: OFDI Capsule Imaging
Celiac Disease Clinical Trial 2023: OFDI Capsule Highlights & Side Effects. Trial Name: NCT02202681 — N/A
OFDI Capsule (Imaging Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02202681 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
How old are they?
65+
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule
Guillermo Tearney 2013. "Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02202681.
All > Celiac Disease
~2 spots leftby Apr 2025
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