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Completed

NCT Number: NCT02204150

Study to Image the Esophagus Using the OFDI Capsule

The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Digestive System Diseases Eosinophilia Eosinophilic Esophagitis Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders Neoplasms Precancerous Conditions

Age range

16 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 56 subjects with Barrett's Esophagus, EoE and healthy volunteers 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.

As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A previous diagnosis of Barrett's Esophagus
  • OR a previous diagnosis of EoE
  • OR a previous diagnosis of Gastroesophageal reflux disease (GERD)
  • Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE
  • Subject must be able to give informed consent

Exclusion criteria

  • Subjects with known esophageal strictures, intestinal strictures or dysphagia
  • OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease

Treatment and study plan

OFDI Capsule

Device

Imaging of the esophagus using the OFDI Capsule and system

Primary outcomes

  1. Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule

    Time frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes

    Number of subjects from whom the quality OFDI imaging was obtained

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

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

Registry information

Official study title

Pilot Study for Imaging of the Esophagus Using an OFDI Capsule

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jul 30, 2014
Registry last updated
Apr 30, 2019

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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