Diagnostic Tests for Detecting Barrett's Esophagus

No longer recruiting at 1 trial location

Overseen By Amitabh Chak, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Anticoagulants

Disqualifiers: Esophageal varices, Dysphagia, Oropharyngeal tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks a new method to detect Barrett's esophagus, a condition where the esophageal lining changes, often due to acid reflux. It employs a new office-based test, EsoCheck/EsoGuard, to determine its effectiveness in detecting this condition. Participants with a positive result may require a follow-up standard endoscopy, a procedure to examine the esophagus. The trial seeks participants over 50 without long-term heartburn issues but with other risk factors like smoking or central obesity. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to earlier detection methods for Barrett's esophagus.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anti-coagulant drugs that cannot be temporarily stopped, you may not be eligible to participate.

What prior data suggests that this diagnostic method is safe for detecting Barrett's esophagus?

Research has shown that the EsoCheck/EsoGuard (EC/EG) test is safe for most people. Studies have found that the EsoCheck device, which collects cells from the esophagus, is very safe and well-tolerated by patients. The EsoGuard test, which examines these cells, is highly accurate in identifying Barrett's esophagus, with about 90% sensitivity. This means it correctly detects the condition in most cases. The test is also very reliable in ruling out the disease, with a 99% negative predictive value, meaning that if the test result is negative, it is almost certainly correct. Overall, trials have demonstrated that the EC/EG system is a safe option for screening Barrett's esophagus. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EsoCheck and EsoGuard because they offer a non-invasive alternative to detect Barrett's Esophagus, unlike the standard esophago-gastro-duodenoscopy (EGD), which is more invasive and often requires sedation. EsoCheck involves a quick swallowable capsule that collects cells from the esophagus, and EsoGuard analyzes those cells for abnormalities. This combination could make screening for Barrett's Esophagus more accessible and comfortable, potentially leading to earlier detection and treatment.

What evidence suggests that these diagnostic tests are effective for detecting Barrett's esophagus?

Research has shown that the EsoGuard test, used with the EsoCheck device, effectively detects abnormal cells in the esophagus in individuals at risk for Barrett’s esophagus (BE). One study demonstrated that this combination aids in diagnosing BE before it progresses to cancer. In this trial, participants will undergo the EsoCheck/EsoGuard (EC/EG) procedure, proven effective for screening and facilitating the early detection of esophageal cancer. This method is particularly useful for identifying BE in individuals who might not otherwise be tested. The test offers a quick and less invasive alternative to traditional methods like endoscopy. Participants with positive EsoGuard results will be asked to complete a standard of care upper endoscopy, while selected participants with negative results may also undergo a research endoscopy if they consent. ^{4 6 7 8 9}

Who Is on the Research Team?

Amitabh Chak, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals over 50 with no chronic GERD, who have two risk factors for Barrett's Esophagus such as being white, having central obesity, male gender, smoking history or a family history of the condition. They must not have swallowing difficulties or blood clotting issues.

Inclusion Criteria

I haven't had chronic heartburn or acid reflux for 5+ years.

I am over 50 and have at least two risk factors for Barrett's esophagus.

I am over 50 and have at least two risk factors for Barrett's esophagus.

Exclusion Criteria

Inability to provide written informed consent

I don't have health issues that prevent me from undergoing specific esophageal exams or biopsies.

I have experienced heartburn or regurgitation weekly for over five years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Participants complete a study questionnaire and undergo the EsoCheck/EsoGuard procedure to detect Barrett's esophagus

Up to 2 months

1 visit (in-person)

Endoscopy

Participants with positive EsoGuard results undergo standard of care upper endoscopy; selected negative participants may also undergo research EGD

Up to 2 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EsoCheck/EsoGuard (EC/EG)
• Esophago-gastro-duodenoscopy (EGD)

Trial Overview The study aims to test a new office-based diagnostic method called EsoCheck/EsoGuard (EC/EG) against the standard Esophago-gastro-duodenoscopy (EGD) procedure in detecting Barrett's Esophagus in patients without typical GERD symptoms.

How Is the Trial Designed?

Group I: EC/EG & EGD Experimental Treatment 2 Interventions

Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected) If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent

EsoCheck/EsoGuard (EC/EG) is already approved in United States for the following indications:

Approved in United States as EsoCheck/EsoGuard for:

• Detection of Barrett's Esophagus
• Esophageal Precancer Screening

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

Adequate pre-endoscopy preparation and proper sedation, particularly with propofol, significantly enhance patient satisfaction and improve the detection of superficial gastrointestinal lesions during esophageo-gastro-duodenoscopy (EGD).

Innovations like image enhanced endoscopy and magnifying endoscopy have been shown to increase the diagnostic yield for conditions such as squamous cell carcinoma and early gastric cancer, indicating a trend towards more effective diagnostic techniques in EGD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in diagnostic upper endoscopy. Teh, JL., Shabbir, A., Yuen, S., et al.[2020]

Esophageal capsule endoscopy (ECE) demonstrated moderate sensitivity (67%) and specificity (84%) for diagnosing Barrett's esophagus in a study of 96 patients, indicating it may not be reliable as a primary screening tool.

Despite its limitations, ECE could be a suitable alternative for patients who are hesitant to undergo traditional endoscopy (EGD), with potential improvements in accuracy through better ingestion protocols and capsule design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blinded comparison of esophageal capsule endoscopy versus conventional endoscopy for a diagnosis of Barrett's esophagus in patients with chronic gastroesophageal reflux. Lin, OS., Schembre, DB., Mergener, K., et al.[2023]

The transnasal capsule endoscope (EG Scan II) demonstrated high sensitivity (90%) and specificity (91%) for detecting Barrett's esophagus (BE) in a study of 178 participants, making it a reliable alternative to conventional esophagogastroduodenoscopy (C-EGD).

Patients preferred the EG Scan over C-EGD, with 54.2% favoring the new method and reporting higher tolerability scores, indicating that it could be a more acceptable screening tool for at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability, Accuracy, and Safety of Disposable Transnasal Capsule Endoscopy for Barrett's Esophagus Screening. Sami, SS., Iyer, PG., Pophali, P., et al.[2021]

The study involving 50 patients indicates that using Lumevis™, which contains simethicone, N-acetylcysteine, and acetic acid, improves mucosal visualization during esophagogastroduodenoscopy (EGDS) without increasing examination time or complication rates.

The results suggest that this preparation method enhances lesion detection rates, making it a promising addition to routine EGDS procedures, although further prospective studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumevis ™: a new medical device to prepare patients for esophagogastroduodenoscopy. Experimental clinical study. Geraci, G., Palumbo, VD., Fazzotta, S., et al.[2021]

Esophagogastroduodenoscopy (EGD) is a very safe procedure with a low risk of serious complications, making it a reliable option for diagnosing and managing upper gastrointestinal diseases.

EGD is not only effective for diagnosis, especially when paired with biopsies, but it is also increasingly used for therapeutic purposes, potentially reducing the need for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of esophagogastroduodenoscopy in the diagnosis and management of upper gastrointestinal disorders. Cappell, MS., Friedel, D.[2019]

In a study of 192 patients with gastroesophageal reflux disease, 20% of those diagnosed with Barrett's esophagus had inconsistencies in the detection of specialized columnar epithelium between two endoscopic examinations, highlighting challenges in accurate diagnosis.

Approximately 10% of patients showed significant changes in the localization of the lower esophageal sphincter between examinations, which resulted in a change in diagnosis for 18% of patients, indicating variability in diagnostic precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic inconsistencies in Barrett's esophagus. Department of Veterans Affairs Gastroesophageal Reflux Study Group. Kim, SL., Waring, JP., Spechler, SJ., et al.[2016]

In a study of 26 patients undergoing oesophagogastroduodenoscopy (EGD), significant electrocardiographic changes were observed, with 65.4% of patients experiencing tachycardia by the end of the procedure, indicating that heart rate changes are common during EGD.

Despite the presence of various ECG abnormalities, including tachycardia and conduction issues, the study concluded that these changes were not severe enough to require intervention or to stop the procedure, suggesting that EGD is generally safe even in patients with these complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrocardiographic changes during oesophagogastroscopy. Akere, A., Akinwusi, PO., Adeoti, ML.[2013]

Transnasal small-caliber esophagogastroduodenoscopy (TSC-EGD) was successfully performed in 92% of patients and required sedation significantly less often compared to conventional EGD (C-EGD), indicating its feasibility and potential for improved patient comfort.

TSC-EGD caused less gagging and was better tolerated overall than peroral small-caliber EGD (PSC-EGD) and C-EGD, despite being initially more painful on insertion, suggesting it could be a promising alternative for diagnostic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of unsedated transnasal small-caliber esophagogastroduodenoscopy (EGD) versus peroral small-caliber EGD versus conventional EGD. Preiss, C., Charton, JP., Schumacher, B., et al.[2022]

Citations

1. uhhospitals.org uhhospitals.org/for-clinicians/articles-and-news/articles/2025/05/esocheck-esoguard-revolutionary-invention-transforms-esophageal-cancer-diagnostics

EsoCheck™ & EsoGuard™: Revolutionary Invention ... The EsoGuard DNA test is used to identify abnormal esophageal cells to diagnose BE before it progresses to cancer. The Power of New Technology ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12100536/

Enhancing the Diagnostic Yield of EGD for Diagnosis of ... Compared with screening EGD alone, it improves diagnostic yield. This may help direct more efficient use of endoscopy resources to improve disease detection in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04293458

Study Details | NCT04293458 | Efficacy of EsoGuard on ... The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay on cells collected using the EsoCheck 510(k) cleared device, ...

4. ir.luciddx.com ir.luciddx.com/2025-02-27-Renowned-Investigators-Awarded-8-Million-NIH-Grant-to-Study-Lucid-Diagnostics-EsoGuard-R-in-At-Risk-Patients-without-Symptomatic-GERD

Press Releases - Lucid Diagnostic Investor Relations We aim to utilize EsoCheck and EsoGuard to improve BE detection in this at-risk population that would otherwise go unscreened, and to do so in a ...

5. targetedonc.com targetedonc.com/view/esoguard-be-1-trial-validates-effective-screening-for-esophageal-precancer

EsoGuard BE-1 Trial Validates Effective Screening ... The ESOGUARD BE-1 trial demonstrated that the EsoGuard test, combined with EsoCheck, effectively detects esophageal precancer and supports its use as a ...

6. medrxiv.org medrxiv.org/content/10.1101/2024.06.24.24309401v2.full.pdf

Use of the EsoGuard® Molecular Biomarker Test in Non- ... Levine, D.S., et al., An endoscopic biopsy protocol can differentiate high-grade dysplasia from early adenocarcinoma in Barrett's esophagus.

7. luciddx.com luciddx.com/precancer-detection/esoguard

EsoGuard With ~90% sensitivity and ~99% negative predictive value at detecting Barrett's esophagus1,2,3 and esophageal adenocarcinoma,1,2 the EsoGuard test allows ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9666821/

Novel Screening and DNA Testing for the Detection ... With that being said, both published data and our own extensive experience demonstrate that the EsoCheck collection device is very safe in most patients.

9. medschool.cuanschutz.edu medschool.cuanschutz.edu/deans-office/cu-med-today/featuresarchives/clinical-trial-tests-device-for-screening-esophageal-cancer

Clinical Trial Tests Device for Screening Esophageal Cancer Currently, Wani says, people are only tested for Barrett's esophagus if they have acid reflux symptoms that have been ongoing for five years or have significant ...