Evaluation of Tethered Capsule Endomicroscopy as a Screening Tool for Barrett's Esophagus in the Primary Care Setting
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|ClinicalTrials.gov Identifier: NCT04561791|
Recruitment Status : Enrolling by invitation
First Posted : September 24, 2020
Last Update Posted : September 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Barrett Esophagus Barrett's Esophagus Without Dysplasia Barretts Esophagus With Dysplasia||Device: Tethered Capsule Endomicroscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Tethered Capsule Endomicroscopy as a Screening Tool for Barrett's Esophagus in the Primary Care Setting|
|Actual Study Start Date :||January 2, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Feasibility of TCE & Prevalence of BE
Device: Tethered Capsule Endomicroscopy
Participants will be asked to swallow the TCE. They may use mild numbing spray, and lubrication spray to help swallowing. Imaging will be conducted once the TCE is past the pharynx. We will advance the TCE until the stomach and then slowly pull the TCE back up the esophagus. This may be repeated twice.
- Subject Tolerability of TCE swallow [ Time Frame: During the single study visit (avg 30.mins), and before leaving, the participant will fill out the tolerability survey ]We will ask the participant about their comfort level throughout the procedure. They will be asked to score the tolerability of the procedure using a scoring system from 0-10. 0= the least tolerable, 10= the most tolerable.
- Prevalence of Barrett's esophagus within the single PCP cohort. [ Time Frame: Imaging data is collected during the procedure, and analyzed within 1 year of collection. ]The PI will identify signs of Barrett's esophagus from the imaging data. This is a qualitative assessment performed by the PI, as this imaging technique is to novel to have standard quality grading.
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): NCT04561791
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Guillermo Tearney, M.D, PhD.||Massachusetts General Hospital|