Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT02202681
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • OFDI Capsule — DEVICE
    Imaging of the duodenum with the OFDI capsule and system

Study Details

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.

Key Dates

Start date
Sep 16, 2013
Status verified
Oct 2025
Primary completion
Oct 28, 2026
Completion
Jul 31, 2028

Study Design

Enrollment
108 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: OFDI Capsule Imaging
    Participant will swallow the OFDI Capsule and imaging will be performed using the OFDI system.

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Celiac disease
By specialty
GastroenterologyAutoimmune disease
By research site
Massachusetts General Hospital· Boston, MA

Related Studies