Testing a new imaging capsule for Barrett's Esophagus
Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System
This study is testing a new imaging capsule to see if it can safely and easily take pictures of the esophagus in both healthy people and those with Barrett's Esophagus.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 14 Years to 85 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT02947971 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with a previous diagnosis of Barrett's Esophagus or healthy volunteers meeting the study criteria.
Not a fit: Patients over 70 years of age or those with swallowing difficulties, strong gag reflex, or esophageal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging technique could enhance the diagnosis and monitoring of Barrett's Esophagus, leading to better patient outcomes.
How similar studies have performed: While this approach is innovative, similar imaging techniques have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.