Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule
Celiac Disease · Healthy
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 16 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 108 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule to image the duodenum.
A total of 108 participants (36 healthy and 72 with clinically suspected or diagnosed Celiac disease) 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.
Read the full description
Participants 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Participant must be over 18 years for healthy volunteers
- Participants must be over 16 years for patients with Celiac disease
- Participant must be able to give informed consent
Exclusion Criteria:
- Participants with an inability to swallow pills or capsules.
- Participants with esophageal or intestinal fistulas.
- Participants with known esophageal or intestinal strictures resulting in a luminal diameter smaller than the diameter of the capsule.
- Participants with a history of intestinal Crohn's disease.
- Women who are pregnant.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
OFDI Capsule Imaging
Participant will swallow the OFDI Capsule and imaging will be performed using the OFDI system.
Device: OFDI Capsule
OFDI Capsule DEVICE
Imaging of the duodenum with the OFDI capsule and system
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule
Time frame: 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 participant will be asked for feedback about tolerability of the procedure using a questionnaire.
Feasibility of OFDI Imaging in subjects swallowing the OFDI capsule
Time frame: 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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Massachusetts General HospitalBoston, Massachusetts, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- Massachusetts General Hospital
- Study start
- Sep 16, 2013 Actual
- Primary completion
- Oct 28, 2028 Estimated
- Study completion
- 2030-07 Estimated
- First posted
- Jul 29, 2014 Estimated
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Pilot Study for Imaging of the Duodenum Using an OFDI Capsule
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026