Clinical trial NCT03459339: Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Official title: Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Barrett Esophagus
Keywords: Barrett's Esophagus
Natural History
Capsule
OCT
Tethered Capsule Endomicroscopy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Mayo Clinic
name: Kansas City Veteran Affairs Medical Center
name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2018-03-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A hundred patients are enrolled in year 1 in each of five participating centers.
Primary purpose: BASIC_SCIENCE

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

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 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 subjects diagnosed with Barrett's Esophagus and undergoing surveillance endoscopy.

Eligibility criteria: Inclusion Criteria:

* Subjects over the age of 18
* Subjects who are capable of giving informed consent
* Subjects with a diagnosis of BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,
* Subjects who had or will have a standard of care EGD within 15 months
* Subjects must have no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure

Exclusion Criteria:

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

Primary outcomes:
measure: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Kansas City
country: United States
facility: VA Medical Center
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: MGH
name: Guillermo Tearney, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dong J, Grant C, Vuong B, Nishioka N, Gao AH, Beatty M, Baldwin G, Baillargeon A, Bablouzian A, Grahmann P, Bhat N, Ryan E, Barrios A, Giddings S, Ford T, Beaulieu-Ouellet E, Hosseiny SH, Lerman I, Trasischker W, Reddy R, Singh K, Gora M, Hyun D, Queneherve L, Wallace M, Wolfsen H, Sharma P, Wang KK, Leggett CL, Poneros J, Abrams JA, Lightdale C, Leeds S, Rosenberg M, Tearney GJ. Feasibility and Safety of Tethered Capsule Endomicroscopy in Patients With Barrett's Esophagus in a Multi-Center Study. Clin Gastroenterol Hepatol. 2022 Apr;20(4):756-765.e3. doi: 10.1016/j.cgh.2021.02.008. Epub 2021 Feb 4.