EsoCheck + EsoGuard for Barrett's Esophagus and Esophageal Adenocarcinoma

(ESOGUARDBE2 Trial)

Not currently recruiting at 36 trial locations

Overseen By Karyms Luna Miller

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Lucid Diagnostics, Inc.

Must be taking: Proton pump inhibitors

Must not be taking: Anti-coagulants

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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new method for detecting Barrett's Esophagus (a condition where the esophagus lining changes) and esophageal adenocarcinoma (a type of cancer). It compares two methods: a traditional scope procedure called Esophagogastroduodenoscopy (EGD) and a non-invasive test using EsoCheck (a device) and EsoGuard (a diagnostic assay). The trial seeks participants who have experienced GERD (acid reflux) for 5 or more years and meet other criteria, such as being Caucasian, a current or past smoker, or having a close relative with Barrett’s Esophagus or esophageal cancer. Participants should avoid solid food for at least two hours before the EsoCheck procedure. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that may improve early detection methods.

Will I have to stop taking my current medications?

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

What prior data suggests that the EsoCheck device and EsoGuard assay are safe for detecting Barrett's Esophagus and esophageal adenocarcinoma?

Research has shown that EsoCheck and EsoGuard are generally easy for patients to handle. In one study, 85% of participants proceeded to have an endoscopy after using EsoGuard, indicating that the procedure is not too uncomfortable. EsoCheck is a simple tool that collects cells from the esophagus, the tube connecting the throat to the stomach. It is minimally invasive and has a 92% accuracy rate, correctly identifying conditions like Barrett's Esophagus and esophageal cancer in 92 out of 100 cases. The high level of patient follow-up and accuracy suggests that these methods are safe and well-accepted. Overall, evidence indicates that these are safe options for detecting issues in the esophagus. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EsoCheck and EsoGuard because they offer a less invasive way to detect Barrett's Esophagus and esophageal adenocarcinoma. Unlike the standard esophagogastroduodenoscopy (EGD) procedure, which involves a scope down the throat, EsoCheck uses a swallowable capsule to collect esophageal cells, making it more comfortable for patients. EsoGuard then analyzes these cells for cancer risk markers, providing a quick and non-invasive assessment. This approach could make screening more accessible and encourage earlier detection, potentially improving outcomes for patients.

What evidence suggests that the EsoCheck and EsoGuard system is effective for detecting Barrett's Esophagus and esophageal adenocarcinoma?

Studies have shown that the EsoGuard test, when used with the EsoCheck device, effectively detects early signs of esophageal cancer, including Barrett's Esophagus (BE) and esophageal adenocarcinoma (EAC). The EsoGuard BE-1 trial confirmed its potential as a reliable screening tool. Participants in this trial will undergo both the EsoGuard lab assay, which runs on distal esophageal cells collected with the non-invasive EsoCheck device, and Esophagogastroduodenoscopy (EGD) with or without biopsies. EsoCheck has a sensitivity of 92.9%, correctly identifying 92.9% of people with the disease, which is promising for screening. This method helps identify more individuals who might need further testing, improving the chances of diagnosing BE compared to traditional methods. ^{1 3 5 6 7}

Who Is on the Research Team?

Michelle McDermott

Principal Investigator

Lucid Diagnostics, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

≥5 years either of Gastroesophageal Reflux Disease (GERD) symptoms, GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control is achieved or not), or any combination of treated and untreated periods, as long the cumulative total is at least 5 years

All Patients:

Men aged 50 years and above

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-In

Initial phase to derive optimal numerical cutoffs for EsoGuard assay using data from enrolled cases and controls

Up to 5 weeks

Efficacy

Phase to assess the sensitivity and specificity of the EsoGuard assay on esophageal cells collected using EsoCheck

Up to 5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EsoCheck
• EsoGuard Assay
• Esophagogastroduodenoscopy

How Is the Trial Designed?

Group I: EsoCheck and EsoGuard vs. EGD with or without biopsies Experimental Treatment 2 Interventions

All subjects will undergo both the EsoGuard lab assay run on distal esophageal cells collected with EsoCheck (non-invasive esophageal cell sample collection) device followed by Esophagogastroduodenoscopy (EGD) with or without biopsies

Who Is Running the Clinical Trial?

Lucid Diagnostics, Inc.

Lead Sponsor

Trials

7

Recruited

1,700+

Citations

1. luciddx.com luciddx.com/clinical-data

Clinical Data The study showcases the effectiveness of EsoCheck, a non-endoscopic device, in providing esophageal cell samples that can be used for a multitude of cytology ...

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

Enhancing the Diagnostic Yield of EGD for Diagnosis of ... EG triage enriches the population undergoing EGD for BE detection. Compared with screening EGD alone, it improves diagnostic yield.

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. medrxiv.org medrxiv.org/content/10.1101/2024.03.15.24304354v1.full-text

Non-endoscopic screening for Barrett's esophagus and ... Esocheck sensitivity of 92.9% (95% CI 66.1, 99.8) is therefore reassuring as acceptable for screening based on previously reported patient ...

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. ir.luciddx.com ir.luciddx.com/2024-12-11-Prospective-Clinical-Utility-Study-of-Lucid-Diagnostics-EsoGuard-R-Esophageal-DNA-Test-Accepted-for-Peer-Reviewed-Publication

Prospective Clinical Utility Study of Lucid Diagnostics ... The study documented an exceptionally high 85% patient compliance with referral to confirmatory upper endoscopy (EGD) following EsoGuard esophageal precancer ...

7. 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 new, state-of-the-art, minimally invasive technologies will be used to screen and identify patients at risk of developing esophageal cancer (EAC).