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NCT Number: NCT02422433

Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule

The purpose of this research is to test the feasibility, sensitivity, and specificity of the marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus (BE).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General hospital

Boston, Massachusetts, 02114, United States

About this study

A total of 130 participants scheduled to undergo esophagogastroduodenoscopy (EGD) will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.

OFDI real-time images will be used for targeting of the region to be marked. Once in position, two cautery marks will be made to only the superficial layers of the esophageal mucosa. Following cautery marking, the capsule will be lowered in the esophagus and marked regions of interest will be reimaged for confirmation of the placement of potential cautery marks.

Immediately following the completion of the experimental procedure, the standard of care with the performance of the surveillance endoscopy will be performed. Images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be undergoing an EGD.
  • Patients must be over the age of 18.
  • Patients must be able to give informed consent.

Exclusion criteria

  • Patients who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure.
  • OR patients with a history of hemostasis disorders.
  • OR patients with esophageal strictures.

Treatment and study plan

OFDI Capsule Marking

Device

Marking and imaging of the esophagus using the OFDI Capsule and system.

Primary outcomes

  1. Feasibility of the marking OFDI capsule for diagnosing BE by comparing OFDI images and biopsy diagnosis

    Time frame: It is expected that the total experimental time including swallowing the OFDI capsule OFDI, OFDI imaging, and removal of the OFDI capsule will take approximately 20 minutes

    The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

Secondary outcomes

  1. Sensitivity of the marking OFDI Capsule to correctly detect and mark the region of interest in BE

    Time frame: It is expected that the total experimental time including swallowing the OFDI capsule OFDI, marking the region of interest, OFDI imaging, and removal of the OFDI capsule will take approximately 20 minutes

    The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2014
Primary completion
2027
Study completion
2029
First posted
Apr 21, 2015
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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