Testing a new imaging capsule for Barrett's Esophagus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to evaluate a novel distal scanning capsule and a compact optical frequency domain imaging (OFDI) system in both healthy individuals and those diagnosed with Barrett's Esophagus (BE). The study will enroll ten healthy volunteers and ten BE patients to assess the ease of use, safety, and feasibility of the imaging system. The capsule, tethered for controlled navigation, will capture real-time images of the esophagus, which will be analyzed post-procedure. This pilot study serves as a precursor to a larger multicenter clinical trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* A previous diagnosis of BE (not an inclusion criteria for healthy volunteers)
* Participants 18 years and older with a previous diagnosis of GERD
* Participants 14 years and older with a previous diagnosis of EoE (not an inclusion criteria for healthy volunteers)
* Health participants over the age of 18 but less than 85 years of age
* Participants must be able to give informed consent
* Participants must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.

Exclusion Criteria:

* Participants over 85 years of age
* Participants with the inability to swallow pills and capsules.
* Participants with a strong gag reflex
* Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
* Participants who are pregnant. In case of women of child bearing age, we will ask them if they are pregnant and if unsure; ask them to take a pregnancy test.

Where it's running

• Massachusetts General hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Guillermo Tearney, MD, PhD — Massachusetts General Hospital
• Study coordinator: Juleen Guoy, RN
• Email: Tearneylabtrials@partners.org
• Phone: 617-726-5317

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using a capsule system to detect Barrett's Esophagus

  This study is testing a new capsule system to see if it can help find Barrett's Esophagus in adults who have had an endoscopy recently.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT06748911

• Using tissue, brush, and blood tests to improve cancer risk prediction and quality of life tracking in Barrett's Esophagus

  This will try extra biopsies, esophageal brushings, blood tests, and short questionnaires to see if they can better predict cancer risk and track quality of life for adults with Barrett's Esophagus who are being evaluated for possible early cancer.

  Recruiting at 9 sites University Hospital, Antwerp · Edegem, Antwerpen and 8 other locations · NCT06523374

• Investigating the best biopsy methods for Barrett's Esophagus

  This study is testing different biopsy methods to see which one works best for finding early signs of Barrett's Esophagus in patients, especially in Asian populations.

  Recruiting E-DA Hospital · Kaohsiung City · NCT05818072

• Treatment options for Barrett's Esophagus and related cancer

  This study is looking at how well different treatments work for people with Barrett's esophagus and esophageal cancer to help improve their health and quality of life.

  Recruiting at 4 sites University of Colorado, Denver · Los Angeles, California and 3 other locations · NCT02634645

• Observing Barrett's Esophagus with Dysplasia and Early Cancer

  This study looks at how patients with Barrett's esophagus, especially those with serious changes or early cancer, are managed over time to see how their condition progresses and how well treatments work.

  Recruiting Western Sydney Local Health District · Westmead, New South Wales · NCT02198976

• Project to improve detection of Barrett's Esophagus and related neoplasia

  This study is testing new ways to better detect Barrett's esophagus and early signs of cancer to help improve care for patients with this condition.

  Recruiting Midwest Veterans' Biomedical Research Foundation · Kansas City, Missouri · NCT00590239

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.