Efficacy of EsoGuard Assay on Esophageal Surface Cells Collected With EsoCheck vs EGD for the Diagnosis of BE or EAC (ESOGUARDBE2)
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ClinicalTrials.gov Identifier: NCT04295811 |
Recruitment Status :
Recruiting
First Posted : March 5, 2020
Last Update Posted : October 5, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Barrett Esophagus Esophageal Adenocarcinoma Barretts Esophagus With Dysplasia Barrett's Esophagus Without Dysplasia | Device: EsoGuard (lab assay) Diagnostic Test: Esophagogastroduodenoscopy | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 470 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Multi-center, single arm |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Multicenter Case-Control Study of the Efficacy of EsoGuard on Samples Collected Using EsoCheck, Versus Esophagogastroduodenoscopy, for the Diagnosis of Barrett's Esophagus With and Without Dysplasia, and for Esophageal Adenocarcinoma |
Actual Study Start Date : | June 18, 2020 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: EsoCheck and EsoGuard vs. EGD with or without biopsies
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
|
Device: EsoGuard (lab assay)
EsoGuard assay (LDT) will be used on cells collected using the EsoCheck (510K cleared esophageal cell collection device)
Other Name: EsoCheck (esophageal cell sample collection device) Diagnostic Test: Esophagogastroduodenoscopy Planned EGD to diagnose and/or treat disorders of esophagus, stomach, and small intestine. When abnormal tissues are noted, biopsies of the tissue are taken through the scope to diagnose tissue abnormalities.
Other Name: EGD |
- Primary Efficacy [ Time Frame: Per subject analysis through study completion which is up to approximately 5 weeks ]The primary efficacy endpoint is the sensitivity of EsoGuard. The primary efficacy objectives of this study are to measure the sensitivities of EsoGuard-based diagnosis in 54 cases each of non-dysplastic Barrett's Esophagus (NDBE), low grade dysplasia (LGD), high grade dysplasia (HGD), and intramucosal adenocarcinoma (IMC) in order to assess EsoGuard's ability to detect disease across the entire continuum of disease progression.
- Secondary Efficacy [ Time Frame: Per subject through study completion which is up to approximately 5 weeks ]The secondary efficacy outcome will be the specificity of EsoGuard (which are run on samples collected using EsoCheck) for Controls. Specificity of EsoGuard will be calculated for the controls as the number of controls who test negative via EsoGuard divided by the total number of controls.
- Safety outcome of EsoCheck Device (510k cleared, non-invasive, esophageal cell collection device) on all patients who undergo the device procedure. [ Time Frame: Per subject through study completion which is up to approximately 5 weeks ]Assessed by evaluation of esophageal abrasions (as visualized during esophagogastroduodenoscopy[EGD]) when EsoCheck and EGD procedures are performed the same day as well as adverse events (AEs) serious adverse events (SAEs), adverse device effects (ADEs), serious adverse devices effects (SADEs), unanticipated serious adverse device effects (USADEs) and Medical Device Deficiency Incidents.

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Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
All Patients:
- Men aged 50 years and above
-
≥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
- No solid foods eaten for at least 2 hours prior to EsoCheck procedure
-
One or more of the following:
- Caucasian race
- Current or past history of chronic smoking
- Body mass index (BMI) of at least 30 kg/m2
- First-degree relative with Barrett's Esophagus (BE) or Esophageal Adenocarcinoma (EAC)
Cases:
- Previous diagnosis of non-dysplastic Barrett's Esophagus (NDBE), low grade dysplasia (LGD), high grade dysplasia (HGD), and/or intramucosal adenocarcinoma (IMC)
- Diagnosis by esophagogastroduodenoscopy (EGD) (with exception of NDBE) was within 4 months prior to study enrollment
- Indicated for surveillance EGD or for therapeutic EGD
- Able to provide, by day of study EGD, the original glass slide(s) of biopsy specimens from most recent prior EGD
Exclusion Criteria:
- Inability to provide written informed consent
- On anti-coagulant drug(s) that cannot be temporarily discontinued
- 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
- History of myocardial infarction or cerebrovascular accident within past 6 months
- Any known lesion which, in the opinion of the endoscopist, obstructs greater than 25% of the esophageal lumen
- Prior participation in PR-0139/EG-CL-101 (Lucid BE Screening Study)
- Prior EGD during which a therapeutic procedure such as, but not limited to, ablation, cryotherapy or endoscopic mucosal resection, was performed for the treatment of BE and/or EAC

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04295811
Contact: Randy Brown, MS | 212-949-4319 | RWB@LucidDx.com | |
Contact: Lisa Gott, RN, BA | LLG@lucidDX.com |
United States, Alabama | |
Lucid Investigative Site | Not yet recruiting |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Lucid Investigative Site | Not yet recruiting |
Orange, California, United States, 92868 | |
United States, Colorado | |
Lucid Investigative Site | Not yet recruiting |
Aurora, Colorado, United States, 80045 | |
Lucid Investigative Site | Not yet recruiting |
Englewood, Colorado, United States, 80113 | |
United States, District of Columbia | |
Lucid Investigative Site | Not yet recruiting |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Lucid Investigative Site | Recruiting |
Jacksonville, Florida, United States, 32256 | |
United States, Illinois | |
Lucid Investigative Site | Not yet recruiting |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
Lucid Investigative Site | Not yet recruiting |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Lucid Investigative Site | Not yet recruiting |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Lucid Investigative Site | Not yet recruiting |
Ann Arbor, Michigan, United States, 48109 | |
United States, Missouri | |
Lucid Investigative Site | Not yet recruiting |
Saint Louis, Missouri, United States, 63110 | |
United States, New Hampshire | |
Lucid Investigative Site | Not yet recruiting |
Lebanon, New Hampshire, United States, 03756 | |
United States, New York | |
Lucid Investigative Site | Recruiting |
New Hyde Park, New York, United States, 11030 | |
Lucid Investigative Site | Not yet recruiting |
Rochester, New York, United States, 14620 | |
United States, North Carolina | |
Lucid Investigative Site | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Oregon | |
Lucid Investigative Site | Not yet recruiting |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Lucid Investigative Site | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Lucid Investigative Site | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Rhode Island | |
Lucid Investigative Site | Not yet recruiting |
Providence, Rhode Island, United States, 02903 | |
United States, South Carolina | |
Lucid Investigative Site | Not yet recruiting |
Charleston, South Carolina, United States, 29425 | |
Lucid Investigative Site | Not yet recruiting |
Greenville, South Carolina, United States, 29615 | |
United States, Tennessee | |
Lucid Investigative Site | Recruiting |
Knoxville, Tennessee, United States, 37909 | |
Lucid Investigative Site | Recruiting |
Nashville, Tennessee, United States, 37212 | |
United States, Texas | |
Lucid Investigative Site | Not yet recruiting |
Austin, Texas, United States, 78712 | |
Lucid Investigative Site | Recruiting |
Dallas, Texas, United States, 75246 | |
Lucid Investigative Site | Recruiting |
Houston, Texas, United States, 77030 | |
United States, Utah | |
Lucid Investigative Site | Recruiting |
Salt Lake City, Utah, United States, 84132 | |
United States, Virginia | |
Lucid Investigative Site | Recruiting |
Richmond, Virginia, United States, 23249 | |
Lucid Investigative Site | Not yet recruiting |
Richmond, Virginia, United States, 23298 |
Study Director: | Randy B, MS | Lucid Diagnostics, Inc. |
Responsible Party: | Lucid Diagnostics, Inc. |
ClinicalTrials.gov Identifier: | NCT04295811 |
Other Study ID Numbers: |
PR-0138 / EG-CL-102 |
First Posted: | March 5, 2020 Key Record Dates |
Last Update Posted: | October 5, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Adenocarcinoma Barrett Esophagus Esophageal Neoplasms Hyperplasia Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pathologic Processes |
Precancerous Conditions Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms |