Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
|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: NCT02994693|
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : September 23, 2020
|Condition or disease||Intervention/treatment|
|Barrett Esophagus Barretts Esophagus With Dysplasia||Device: OFDI capsule imaging|
The MGH will be the first site in the multi-center study to begin enrolling. At the MGH 100 subjects with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled.
Each subject will undergo a minimum of 2 esophagogastroduodenoscopies (EGD), one around the time of inclusion into the study and one at the end of the study, and 4 TCE imaging sessions (baseline, 1-year, 2-years and at the end of the 3-years follow-up). If it is determined by the treating physician that additional EGDs are needed, for extended follow-up or treatment, capsule imaging will be performed whenever possible.
Patients will have received written information prior to the day of the capsule procedure and patients will have another chance to discuss the procedure with the study coordinator and clinical study staff during the consent process prior to the capsule procedure. Participation in this study is completely voluntary, and the patient can stop the procedure at any time.
For each of the imaged patients, inclusion criteria and clinical characteristics such as age, sex, body mass index (BMI), current medication regimen, smoking history and GI related history will be recorded in the clinical form.
Subjects will be seated and asked to sip water to facilitate swallowing the capsule.
The device will be operated by experienced study staff trained in the procedure such as a registered nurse or one of the endoscopist co-investigators in this study. Emergency phone and/or pager contact of the collaborating GI clinician(s) will be provided. They will also be accessible during the procedure if any problems are encountered that require their expertise.
Imaging will be performed in the same manner as in our other current IRB approved tethered capsule endomicroscopy studies. The capsule position will be controlled manually via the tether outside of the subject's mouth by the catheter operator. Recorded real-time cross-sectional images displayed on the monitor and distance marks on the tether will be used for confirmation of capsule position in the esophagus. Images will be viewed in real time to determine when the capsule has reached the stomach. The resistance of the tether can also give information of the cardia position. Once in the stomach, the capsule will be gradually pulled back up through the esophagus to the mouth, also while imaging. The capsule may be repositioned for imaging up to 4 times up and 4 times down the esophagus. The subject may be asked to swallow a different size capsule (ranging from 5-12.8 mm in diameter and 20-30 cm in length) to obtain the best distal esophageal images. It is expected that the maximum experimental time including swallowing the capsule, the imaging procedure, and removal of the capsule will take approximately 10 minutes in total.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
OFDI capsule imaging
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.
Device: OFDI capsule imaging
Imaging of Barrett's esophagus (BE) using OFDI capsule imaging
- Longitudinal assessment of the Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy [ Time Frame: Approximate 25 minutes visit (10 min image acquisition) ]An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. They will assess how the images change over time.
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): NCT02994693
|Contact: Anna Gao, RN||617-643-6092||Tearneylabtrials@partners.org|
|Contact: Anita Chung, RN||617-724-4515||Tearneylabtrials@partners.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Anna Gao, RN 617-643-6092 Tearneylabtrials@partners.org|
|Principal Investigator:||Guillermo Tearney, MD, PhD||Massachusetts General Hospital|