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NCT Number: NCT03459339

Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

The goal of this research is to follow Barrett's Esophagus participants for 3 years using the tethered capsule endomicroscopy device with distal scanning and a compact imaging system in a multi-site clinical study.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic - Jacksonville, Jacksonville, Florida, United States

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About this study

The progression of Barrett's Esophagus will be studied over time using tethered capsule endomicroscopy imaging and will be performed at 5 different clinical centers in the US, namely: Massachusetts General Hospital (MGH),(MA), Mayo Clinic Jacksonville (FL), Mayo Clinic Rochester (MN), Columbia University Medical Center (NY), Kansas City VA Medical Center (MO). MGH will be the coordinating center of this multicenter study. Dr G. Tearney will serve as study Sponsor Investigator.

The purpose of this study is to determine the natural history of Barrett's Esophagus using TCE in participants diagnosed with Barrett's Esophagus and undergoing surveillance endoscopy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants over the age of 18
  • Participants who are capable of giving informed consent
  • Participants with a diagnosis of BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy
  • Participants who had or will have a standard of care EGD within 15 months, exceptions to this can be submitted to the coordinating center (MGH) for approval

Exclusion criteria

  • Participants with prior endoscopic ablation or resection treatment of BE at enrollment visit
  • Participants with esophageal fistula and/or esophageal strictures
  • Participants with the inability to swallow capsules
  • Concomitant chemotherapy treatment
  • Self reported pregnancy

Treatment and study plan

Tethered Capsule Endomicroscopy (TCE)

Device

Tethered Capsule Endomicroscopy will be used to detect Barrett's Esophagus

Other names: OFDI capsule imaging

Primary outcomes

  1. Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

    Time frame: 4 years

    We will be measuring the size of the area affected by Barrett's.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Columbia University
  • Kansas City Veteran Affairs Medical Center
  • Mayo Clinic
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2017
Primary completion
2027
Study completion
2028
First posted
Mar 8, 2018
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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