Imaging the Duodenum Using an Optical Frequency Domain Im... | NCT02202681

Studies
Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

NCT02202681

Sponsor

Massachusetts General Hospital

Status

Enrolling by invitation

Last Update Posted

Oct 22, 2025Actual

Enrollment

108Estimated

Phase

Not Applicable

Conditions

Celiac Disease
Healthy

Interventions

OFDI Capsule

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 16, 2013Actual

Primary Completion Date

Oct 28, 2026Estimated

Completion Date

Jul 2028Estimated

First Submitted Date

Jun 12, 2014

First Submission Date that Met QC Criteria

Jul 25, 2014

First Posted Date

Jul 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2025

Last Update Posted Date

Oct 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guillermo Tearney, Principal Investigator, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OFDI Capsule Imaging	Experimental	Participant will swallow the OFDI Capsule and imaging will be performed using the OFDI system.	Device: OFDI Capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OFDI Capsule	Device	Imaging of the duodenum with the OFDI capsule and system	OFDI Capsule Imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guillermo Tearney, MD., PhD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002446	Celiac Disease

Ancestor Terms

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided