Study to Evaluate EnteroTracker® as a Sampling Method to Screen for Barrett's Esophagus/Esophageal Cancer

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05706025
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • EnteroTracker — DEVICE
    The EnteroTracker® is a capsule device that includes an absorbent string.

Study Details

The purpose of this study is to determine whether the EnteroTracker can obtain biomarkers that have been studied to be significant in screening BE and EAC. The current standard of care is endoscopic biopsy where the pathologist will visualize the tissue under a microscope to interpret diagnosis. Another goal of this study is to understand tolerance of the procedure so it might be used in an at-home setting.

Key Dates

Start date
May 31, 2023
Status verified
Apr 2025
Primary completion
Mar 1, 2028
Completion
Mar 1, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Enterotracker
    The EnteroTracker® is a capsule device that includes an absorbent string. The trailing end of the string is taped to the cheek and the capsule is swallowed with 8-12 ounces of water. The capsule dislodges the string as it travels to the proximal small intestine. The capsule continues through the remainder of the GI tract, leaving a string in the esophagus, stomach, and duodenum. Following a 60-minute dwell time, the string is removed via the subjects' mouth and processed for analysis. Subjects will be coached to ease any potential anxieties and answer any questions. A preparatory video can be used for education if desired.

Primary Outcome Measure

Study Esophageal Mucosal Samples using Enterotracker Device [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045-

Find similar trials in Aurora, CO

By condition
Esophageal cancer
By specialty
OncologyGI oncology
By research site
University of Colorado· Aurora, CO

Related Studies