Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule
Launched by MASSACHUSETTS GENERAL HOSPITAL · Jul 25, 2014
Trial Information
Current as of August 19, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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.
About Massachusetts General Hospital
Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Patients applied
Trial Officials
Guillermo Tearney, MD., PhD
Principal Investigator
Massachusetts General Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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