ClinConnect ClinConnect Logo
Search / Trial NCT02202681

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

Duodenum Optical Frequency Domain Imaging (Ofdi) Optical Coherence Tomography Imaging Celiac Disease

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.

Locations

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Guillermo Tearney, MD., PhD

Principal Investigator

Massachusetts General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials