Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Primary Purpose
Barrett Esophagus
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tethered Capsule Endomicroscopy (TCE)
Sponsored by
About this trial
This is an interventional basic science trial for Barrett Esophagus focused on measuring Barrett's Esophagus, Natural History, Capsule, OCT, Tethered Capsule Endomicroscopy
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
Sites / Locations
- Mayo Clinic - Jacksonville
- Massachusetts General Hospital
- Mayo Clinic - Rochester
- VA Medical Center
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental OFDI capsule imaging
Arm Description
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system. Intervention: 'Tethered Capsule Endomicroscopy (TCE) Imaging of Barrett's esophagus using OFDI capsule
Outcomes
Primary Outcome Measures
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
We will be measuring the size of the area affected by Barrett's. The measurements will done in cm.
Secondary Outcome Measures
Full Information
NCT ID
NCT03459339
First Posted
February 6, 2018
Last Updated
January 12, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Columbia University, Mayo Clinic, Kansas City Veteran Affairs Medical Center, National Institutes of Health (NIH), National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03459339
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Columbia University, Mayo Clinic, Kansas City Veteran Affairs Medical Center, National Institutes of Health (NIH), National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus
Keywords
Barrett's Esophagus, Natural History, Capsule, OCT, Tethered Capsule Endomicroscopy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A hundred patients are enrolled in year 1 in each of five participating centers.
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental OFDI capsule imaging
Arm Type
Experimental
Arm Description
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.
Intervention: 'Tethered Capsule Endomicroscopy (TCE) Imaging of Barrett's esophagus using OFDI capsule
Intervention Type
Device
Intervention Name(s)
Tethered Capsule Endomicroscopy (TCE)
Other Intervention Name(s)
OFDI capsule imaging
Intervention Description
Tethered Capsule Endomicroscopy will be used to detect Barrett's Esophagus
Primary Outcome Measure Information:
Title
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Description
We will be measuring the size of the area affected by Barrett's. The measurements will done in cm.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Tearney, MD, PhD
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33549871
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.
Results Reference
derived
Learn more about this trial
Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
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