This clinical trial evaluates the effectiveness and tolerability of a minimally-invasive sampling device called EnteroTracker to obtain mucosal samples from the esophagus of patients with Barrett's esophagus or esophageal cancer. EnteroTracker is a capsule-string device which is swallowed, absorbs samples from the esophagus, and then is removed via the mouth. It may be useful in obtaining samples of biomarkers shown to be significant in screening for Barrett's esophagus and esophageal cancers. If the EnteroTracker is able to obtain samples of these biomarkers, it may be useful in screening patients for Barrett's esophagus and esophageal cancer in a less invasive manner than current standards of care.
Additional locations may be listed on ClinicalTrials.gov for NCT05706025.
Locations matching your search criteria
United States
Colorado
Aurora
UCHealth University of Colorado HospitalStatus: Active
Contact: Sachin Balkrishna Wani
Phone: 720-848-2275
PRIMARY OBJECTIVE:
I. Evaluate the ability and tolerability of the EnteroTracker to capture esophageal mucosal samples in adults with Barrett's esophagus (BE) and/or esophageal adenocarcinoma (EAC) as well as controls.
SECONDARY OBJECTIVE:
I. Determine the ability of the EnteroTracker obtained BE/EAC biomarkers to distinguish between BE and/or EAC from control subjects.
TERTIARY/EXPLORATORY OBJECTIVES:
I. Determine the primary side effects when swallowing or retrieving the EnteroTracker.
II. Evaluate whether a panel of biomarkers may be obtained from the EnteroTracker sample.
OUTLINE:
Participants undergo esophageal sampling with the EnteroTracker, over 60 minutes, while on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorSachin Balkrishna Wani
