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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02202681
Other study ID # 2013-P001405
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 16, 2013
Est. completion date July 2028

Study information

Verified date May 2024
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 24 subjects 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.


Description:

Subjects 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 108
Est. completion date July 2028
Est. primary completion date October 28, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Subject must be over 18 years for healthy volunteers - Subjects must be over 16 years for patients with Celiac disease - Subject must be able to give informed consent Exclusion Criteria: - Subjects with an inability to swallow pills or capsules. - Subjects with esophageal or intestinal fistulas. - Subjects with known esophageal or intestinal strictures resulting in a luminal diameter smaller than the diameter of the capsule. - Subjects with a history of intestinal Crohn's disease. - Women who are pregnant.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
OFDI Capsule
Imaging of the duodenum with the OFDI capsule and system

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule After participating in the study, the subject 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.
Primary 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
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