Celiac DiseaseNCT02202681
Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule
A study testing OFDI Capsule in people with Celiac Disease and Healthy, run by Massachusetts General Hospital at 1 site in United States.
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 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease, Healthy
- What is being tested?
- OFDI Capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2013to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pilot Study for Imaging of the Duodenum Using an OFDI Capsule
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 detailed 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.
- Conditions
- Celiac Disease, Healthy
- Being tested
- OFDI Capsule
- Keywords
- Duodenum, Optical Frequency Domain Imaging (OFDI), Optical Coherence Tomography, Imaging, Celiac Disease
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFDI CapsuleDevice
Imaging of the duodenum with the OFDI capsule and system
| Study group | Role | What they receive |
|---|---|---|
| OFDI Capsule Imaging | Experimental | Participant will swallow the OFDI Capsule and imaging will be performed using the OFDI system. Receives: Device: OFDI Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule
After participating in the study, the participant will be asked for feedback about tolerability of the procedure using a questionnaire.
Measured: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours.
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.
Measured: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study start16 Sep 2013
- Primary completion28 Oct 2026 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Tearney, Massachusetts General Hospital
- Investigators
- Guillermo Tearney, MD., PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202681
- Sponsor's protocol ID
- 2013-P001405
- Status last verified
- Oct 2025
- First submitted
- 12 Jun 2014
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Imaging of the Duodenum Using an OFDI Capsule
- ClinicalTrials.gov ID
- NCT02202681
- Acronym / sponsor ID
- 2013-P001405
- Conditions
- Celiac Disease, Healthy
- Keywords
- Duodenum, Optical Frequency Domain Imaging (OFDI), Optical Coherence Tomography, Imaging, Celiac Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 16 Sep 2013 (actual)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OFDI Capsule Imaging | Experimental | Device: OFDI CapsuleParticipant will swallow the OFDI Capsule and imaging will be performed using the OFDI system. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OFDI CapsuleImaging of the duodenum with the OFDI capsule and system | Device | OFDI Capsule Imaging |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillermo Tearney, MD., PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OFDI Capsule in people with Celiac Disease and Healthy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.