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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA184102-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Columbia University | OTHER |
| Mayo Clinic | OTHER |
| Kansas City Veteran Affairs Medical Center | FED |
| National Institutes of Health (NIH) |
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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 clinical study.
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 participants diagnosed with Barrett's Esophagus and undergoing surveillance endoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental OFDI capsule imaging | Experimental | Participants 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tethered Capsule Endomicroscopy (TCE) | Device | Tethered Capsule Endomicroscopy will be used to detect Barrett's Esophagus |
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| Measure | Description | Time Frame |
|---|---|---|
| Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy | We will be measuring the size of the area affected by Barrett's. | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Tearney, MD, PhD | MGH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33549871 | Derived | 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. |
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| NIH |
| National Cancer Institute (NCI) | NIH |
100 participants are enrolled in year 1 in each of five participating centers.
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| Boston |
| Massachusetts |
| 02114 |
| United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| VA Medical Center | Kansas City | Missouri | 64128 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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