Status:
ACTIVE_NOT_RECRUITING
Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Columbia University
Mayo Clinic
Conditions:
Barrett Esophagus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 c...
Detailed Description
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 Ge...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03459339
Start Date
April 4 2017
End Date
December 1 2028
Last Update
October 22 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
4
VA Medical Center
Kansas City, Missouri, United States, 64128