Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03459339 |
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Recruitment Status :
Recruiting
First Posted : March 8, 2018
Last Update Posted : July 22, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Barrett Esophagus | Device: Tethered Capsule Endomicroscopy (TCE) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | A hundred patients are enrolled in year 1 in each of five participating centers. |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy |
| Actual Study Start Date : | April 4, 2017 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Experimental OFDI capsule imaging
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 |
Device: Tethered Capsule Endomicroscopy (TCE)
Tethered Capsule Endomicroscopy will be used to detect Barrett's Esophagus
Other Name: OFDI capsule imaging |
- Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy [ Time Frame: 4 years ]We will be measuring the size of the area affected by Barrett's. The measurements will done in cm.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459339
| Contact: Anna Gao, RN | 617-643-6092 | Tearneylabtrials@partners.org | |
| Contact: Emily Ryan, BS | 617-724-4515 | Tearneylabtrials@partners.org |
| United States, Florida | |
| Mayo Clinic - Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Michael Wallace, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Anna Gao, RN 617-643-6092 Tearneylabtrials@partners.org | |
| Contact: Anita Chung, RN 617-724-4515 Tearneylabtrials@partners.org | |
| United States, Minnesota | |
| Mayo Clinic - Rochester | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Kenneth Wang, MD | |
| United States, Missouri | |
| VA Medical Center | Recruiting |
| Kansas City, Missouri, United States, 64128 | |
| Contact: Prateek Sharma, MD | |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: John Poneros, MD | |
| Principal Investigator: | Guillermo Tearney, MD, PhD | MGH |
| Responsible Party: | Guillermo Tearney, Professor of Pathology, HMS, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT03459339 |
| Other Study ID Numbers: |
2017-P000604 R01CA184102-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 8, 2018 Key Record Dates |
| Last Update Posted: | July 22, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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Barrett's Esophagus Natural History Capsule OCT Tethered Capsule Endomicroscopy |
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Barrett Esophagus Precancerous Conditions Neoplasms |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |