Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms

NCT06687603 | Recruiting DMC FDA Device

• 1 other identifier: CASE10224
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this clinical trial is to develop a method to detect Barrett's esophagus in individuals with a new office based diagnostic test. Barrett's esophagus is a condition in which the flat pink lining of the swallowing tube that connects the mouth to the stomach (the esophagus) becomes damaged by acid reflux. The main question it aims to answer is: Can this approach demonstrate efficacy for screening of Barrett's esophagus? Participants will:

• Participate in a questionnaire.
• Undergo a capsule balloon test, called EsoCheck.
• Have their EsoCheck sample sent to the laboratory for an EsoGuard test, which is used to detect Barrett's esophagus.
• Participants will undergo upper endoscopy as part of standard of care.

Conditions

Barrett Esophagus; Gastroesophageal Reflux; Esophageal Adenocarcinoma

Keywords

Esophagus; Non-endoscopic

Outcome Measures

Primary Outcomes (3)

• Positive predictive value for Barret's Esophagus in EsoCheck/EsoGuard positive participants

  The primary goal of this study is to develop a non-endoscopic screening test for the non-GERD population that provides a PPV \>20%, i.e. at least 2-fold greater than the 10% PPV of society recommended EGD screening of chronic GERD patients with any additional risk factors.

  Up to 5 years

• Barrett's Esophagus prevalence in EsoCheck/EsoGuard test negative subjects from a high-risk GERD negative population

  This study will also perform endoscopy in a sample of EC/EG negative subjects to confirm that BE is enriched in the test positive versus test negative population. This will be measured by the prevalence of BE in a high-risk GERD negative population.

  Up to 5 years

• Tissue origins of true positive versus false positive EsoCheck/EsoGuard tests in non-GERD screening population

  In BE positive cases, biopsies will be taken every 2-cm across the BE segment to map the extent of the field of methylated Vimentin (mVim) and methylated CCNA1 (mCCNA1) DNA detected by EsoGuard.

  Up to 5 years

Study Arms (1)

EsoCheck + EsoGuard

EXPERIMENTAL

Participants will undergo an EsoCheck test. The sample produced by the EsoCheck will be sent to LucidDx where the EsoGuard assay will be performed.

Device: EsoCheck; Diagnostic Test: EsoGuard

Interventions

EsoCheck DEVICE

FDA-approved, non-endoscopic, encapsulated swallowable balloon. EsoCheck will produce a sample which will subsequently be tested with EsoGuard assay. The EsoCheck is performed and completed in approximately 5 minutes.

EsoCheck + EsoGuard

EsoGuard DIAGNOSTIC_TEST

Approved laboratory, methylated DNA panel that detects esophageal neoplasia. The EsoGuard assay tests the EsoCheck samples to detect BE in GERD participants.

EsoCheck + EsoGuard

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing screening colonoscopy are an accessible cohort for BE screening and are also a reasonable representation of the general population. Permission will be obtained from colonoscopy physicians for researchers to contact and recruit patients for this study. Patients without GERD, who are at risk for BE, and who have not had a prior EGD, will be recruited prior to or at the time of scheduled colonoscopy.(9) Those eligible will be:
• Adults who have not had prior EGD within past ten years, and are able to provide informed consent, and who have:
• No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
• No significant dysphagia or odynophagia; but who do have:
• Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
• Adults \> age 50, who also have two or more added risk factors for BE from the set of: central obesity (waist size \> 35 inches for women and \> 40 inches for men), current smoker or smoking history \> 10 pack years, white race, male sex, confirmed history of BE/EAC in at least two family members, with one a first degree relative. While BE is most highly prevalent in white males, a black female over age 50 with obesity and a positive smoking history would also be at increased BE risk and would equally meet eligibility criteria.
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• History of prior EGD procedure in past ten years
• Inability to provide written informed consent
• History of weekly of more frequent heartburn or regurgitation for five or more years
• On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR \> 1.5
• Known history of esophageal varices or esophageal stricture
• Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
• History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
• Oropharyngeal tumor
• History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (5)

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 027599, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44016, United States

RECRUITING

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Barrett Esophagus; Gastroesophageal Reflux; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Study Officials

• Amitabh Chak, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Brock

CONTACT

216-844-3853; Wendy.brock@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All endoscopic images will be reviewed by an examiner who will be blinded to the endoscopy report. BE will be defined as the presence of \> 1 cm of columnar appearing epithelium in the tubular esophagus as confirmed by the blinded reviewer plus the presence of intestinal metaplasia on biopsies. I
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: March 10, 2025
• Primary Completion (Estimated): September 27, 2028
• Study Completion (Estimated): September 27, 2029
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)