Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE (ESOGUARDBE1)
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| ClinicalTrials.gov Identifier: NCT04293458 |
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Recruitment Status :
Completed
First Posted : March 3, 2020
Last Update Posted : January 25, 2023
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Sponsor:
Lucid Diagnostics, Inc.
Information provided by (Responsible Party):
PAVmed Inc. ( Lucid Diagnostics, Inc. )
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Brief Summary:
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, to detect Barrett's Esophagus, with and without dysplasia, and/or Esophageal Adenocarcinoma, in individuals deemed to be at high risk for these conditions (i.e., screening) per ACG guidelines.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Barrett Esophagus Esophageal Adenocarcinoma Barretts Esophagus With Dysplasia Barrett's Esophagus Without Dysplasia | Device: EsoGuard | Not Applicable |
This is a multicenter, single-arm study designed to assess the operating characteristics of the EsoGuard diagnostic assay performed on distal esophageal mucosal cells collected using the EsoCheck cell collection device, compared to the gold standard, for the screening of BE with and without dysplasia and for esophageal adenocarcinoma (EAC), in patients at high risk for BE and for whom a screening EGD is indicated according to ACG-established criteria.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 145 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Multicenter, Single Arm |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | A Multicenter, Single-Arm Study of the Efficacy of EsoGuard(TM) on Samples Collected Using EsoCheck(TM) Versus Esophagogastroduodenoscopy for the Diagnosis of Barrett's Esophagus in an At-Risk Screening Population |
| Actual Study Start Date : | February 28, 2020 |
| Actual Primary Completion Date : | August 22, 2022 |
| Actual Study Completion Date : | August 22, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: EsoCheck vs. EGD with or without biopsies
All subjects will undergo both the EsoCheck (non-invasive esophageal cell sample collection) followed by EGD (with or without biopsies)
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Device: EsoGuard
EsoGuard assay (LDT) will be used on cells collected using EsoCheck (510K cleared esophageal cell collection device) and compared to results of EGD plus biopsies (when taken) |
Primary Outcome Measures :
- Primary Efficacy [ Time Frame: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks ]The sensitivity and specificity of EsoGuard for the diagnosis of BE on samples collected using EsoCheck, wherein the definitive diagnosis of BE is made by concomitant EGD and biopsy.
Secondary Outcome Measures :
- Secondary Efficacy [ Time Frame: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks ]Negative predictive value (NPV) and positive predictive value (PPV), calculated for the observed prevalence and over a range of prevalences from 1 to 15%.
Other Outcome Measures:
- Safety of EsoCheck device administration [ Time Frame: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks ]Assessed by evaluation of AEs/SAEs/ADEs/SADEs/USADEs and Medical Device Deficiency Incidents
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Men aged 50 years old and older
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≥5 years either of
- 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
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One or more of the following risk factors:
- Caucasian race
- Current or past history of cigarette smoking
- BMI of at least 30 kg/m2
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First-degree relative with BE or EAC
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Exclusion Criteria:
- History of prior EGD procedure
- 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
- History of esophageal motility disorder
- Currently implanted Linx device
Information from the National Library of Medicine
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): NCT04293458
Locations
| United States, California | |
| Lucid Investigative Site | |
| Orange, California, United States, 92868 | |
| United States, Colorado | |
| Lucid Investigative Site | |
| Englewood, Colorado, United States, 80113 | |
| United States, Florida | |
| Lucid Investigative Site | |
| Naples, Florida, United States, 34102 | |
| Lucid Investigative Site | |
| Palm Harbor, Florida, United States, 34684 | |
| United States, Georgia | |
| Lucid Investigative Site | |
| Macon, Georgia, United States, 31201 | |
| United States, Idaho | |
| Lucid Investigative Site | |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Illinois | |
| Lucid Investigative Site | |
| Rockford, Illinois, United States, 61107 | |
| United States, Louisiana | |
| Lucid Investigative Site | |
| New Orleans, Louisiana, United States, 70112 | |
| Lucid Investigative Site | |
| Shreveport, Louisiana, United States, 71105 | |
| United States, Michigan | |
| Lucid Investigative Site | |
| Wyoming, Michigan, United States, 49519 | |
| United States, Mississippi | |
| Lucid Investigative Site | |
| Flowood, Mississippi, United States, 39232 | |
| United States, Nebraska | |
| Lucid Investigative Site | |
| Omaha, Nebraska, United States, 68124 | |
| United States, New York | |
| Lucid Investigative Site | |
| New York, New York, United States, 10016 | |
| Lucid Investigative Site | |
| Rochester, New York, United States, 14620 | |
| United States, North Carolina | |
| Lucid Investigative Site | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Oklahoma | |
| Lucid Investigative Site | |
| Oklahoma City, Oklahoma, United States, 73102 | |
| United States, Pennsylvania | |
| Lucid Investigative Site | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Lucid Investigative Site | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Tennessee | |
| Lucid Investigative Site | |
| Knoxville, Tennessee, United States, 37909 | |
| Lucid Investigative Site | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Lucid Investigative Site | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Lucid Investigative Site | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Lucid Investigative Site | |
| Richmond, Virginia, United States, 23249 | |
| Lucid Investigative Site | |
| Richmond, Virginia, United States, 23298 | |
| Spain | |
| Lucid Investigative Site | |
| Madrid, Spain, 28040 | |
| Lucid Investigative Site | |
| Valladolid, Spain, 47012 | |
| Lucid Investigative Site | |
| Zaragoza, Spain, 50009 | |
Sponsors and Collaborators
Lucid Diagnostics, Inc.
Investigators
| Study Director: | Michelle McDermott | Lucid Diagnostics |
| Responsible Party: | Lucid Diagnostics, Inc. |
| ClinicalTrials.gov Identifier: | NCT04293458 |
| Other Study ID Numbers: |
PR-0139 / EG-CL-101 |
| First Posted: | March 3, 2020 Key Record Dates |
| Last Update Posted: | January 25, 2023 |
| Last Verified: | January 2023 |
| 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 |
Additional relevant MeSH terms:
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Barrett Esophagus Neoplasms Precancerous Conditions |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |