New technology for capturing tissue samples in Barrett's Esophagus patients
Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus
NA · Massachusetts General Hospital · NCT03830801
This study is testing a new capsule that patients swallow to take pictures of their esophagus and capture tissue samples to see if it can better identify risks for cancer in people with Barrett's Esophagus.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03830801 on ClinicalTrials.gov |
What this trial studies
This study evaluates a novel approach called in-vivo laser capture microdissection (IVLCM) using a tethered capsule endomicroscope to improve the assessment of Barrett's Esophagus. Patients swallow a capsule that captures images of the esophagus and identifies abnormal tissue in real-time. A laser is then used to capture targeted tissue samples for genomic analysis, allowing for more precise risk assessment of esophageal adenocarcinoma. The study aims to enhance the accuracy of Barrett's Esophagus screening and prognosis.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are undergoing an endoscopy with biopsy for Barrett's Esophagus.
Not a fit: Patients with esophageal strictures or those on certain medications that affect bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could lead to more accurate predictions of cancer risk in Barrett's Esophagus patients.
How similar studies have performed: While this approach is innovative, similar technologies have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have a current or prior diagnosis of Barrett's Esophagus * Participants must be over the age of 18. * Participants must be able to give informed consent. Exclusion Criteria: * Pregnant women. * Participants who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure. * Participants with a history of hemostasis disorders. * Participants with esophageal strictures, resulting in a luminal diameter smaller than the diameter of the capsule. * Participants with a know history of esophageal varices * Participants above 80 years of age
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Gary Tearney, MD., PhD — Massachusetts General Hospital
- Study coordinator: Anita Chung, RN
- Email: Tearneylabtrials@partners.org
- Phone: 617-724-4515
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.
Conditions: Barrett Esophagus, Barrett's Esophagus, EGD, Endoscopy, Biopsy, Tethered Capsule Endomicroscopy, OCT