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Trial record 2 of 4 for:    esocheck

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 : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
PAVmed Inc. ( Lucid Diagnostics, Inc. )

Brief Summary:
The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay (lab developed test) on cells collected using the EsoCheck (501k cleared device) to detect Barrett's Esophagus (BE), with or without dysplasia, and esophageal adenocarcinoma (EAC) as compared to Esophagogastroduodenoscopy (EGD) plus biopsies in both confirmed cases of BE/EAC and in controls (subjects without a prior diagnosis but undergoing screening for BE/EAC)

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

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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

Resource links provided by the National Library of Medicine


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 Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All Patients:

  1. Men aged 50 years and above
  2. ≥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
  3. No solid foods eaten for at least 2 hours prior to EsoCheck procedure
  4. One or more of the following:

    • Caucasian race
    • Current or past history of cigarette smoking
    • Body mass index (BMI) of at least 30 kg/m2
    • First-degree relative with Barrett's Esophagus (BE) or Esophageal Adenocarcinoma (EAC)

Cases:

  1. Previous diagnosis of non-dysplastic Barrett's Esophagus (NDBE), low grade dysplasia (LGD), high grade dysplasia (HGD), and/or intramucosal adenocarcinoma (IMC)
  2. Diagnosis by esophagogastroduodenoscopy (EGD) (with exception of NDBE) was within 4 months prior to study enrollment
  3. Indicated for surveillance EGD or for therapeutic EGD
  4. Able to provide, by day of study EGD, the original glass slide(s) of biopsy specimens from most recent prior EGD

Exclusion Criteria:

  1. Inability to provide written informed consent
  2. On anti-coagulant drug(s) that cannot be temporarily discontinued
  3. Known history of esophageal varices or esophageal stricture
  4. 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
  5. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
  6. Oropharyngeal tumor
  7. History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
  8. History of myocardial infarction or cerebrovascular accident within past 6 months
  9. Any known lesion which, in the opinion of the endoscopist, obstructs greater than 25% of the esophageal lumen
  10. Prior participation in PR-0139/EG-CL-101 (Lucid BE Screening Study)
  11. 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
  12. History of esophageal motility disorder
  13. 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): NCT04295811


Contacts
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Contact: Randy Brown, MS 212-949-4319 RWB@LucidDx.com
Contact: Lisa Gott, RN, BA LLG@lucidDX.com

Locations
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United States, Alabama
Lucid Investigative Site Recruiting
Birmingham, Alabama, United States, 35294
United States, California
Lucid Investigative Site Recruiting
Orange, California, United States, 92868
United States, Colorado
Lucid Investigative Site Recruiting
Aurora, Colorado, United States, 80045
Lucid Investigative Site Recruiting
Englewood, Colorado, United States, 80113
United States, District of Columbia
Lucid Investigative Site Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Lucid Investigative Site Terminated
Jacksonville, Florida, United States, 32256
United States, Illinois
Lucid Investigative Site Not yet recruiting
Chicago, Illinois, United States, 60611
United States, Louisiana
Lucid Investigative Site Recruiting
Shreveport, Louisiana, United States, 71105
United States, Maryland
Lucid Investigative Site Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Lucid Investigative Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Lucid Investigative Site Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Mississippi
Lucid Investigative Site Recruiting
Flowood, Mississippi, United States, 39232
United States, Missouri
Lucid Investigative Site Not yet recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Lucid Investigative Site Recruiting
Omaha, Nebraska, United States, 68124
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 Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Lucid Investigative Site Withdrawn
Providence, Rhode Island, United States, 02903
United States, South Carolina
Lucid Investigative Site Recruiting
Charleston, South Carolina, United States, 29425
Lucid Investigative Site 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 Recruiting
Richmond, Virginia, United States, 23298
Netherlands
Lucid Investigative Site Recruiting
Amsterdam, Netherlands, 1081 HZ
Lucid Investigative Site Not yet recruiting
Eindhoven, Netherlands, 5623 EJ
Lucid Investigative Site Not yet recruiting
Groningen, Netherlands, 9713 GZ
Lucid Investigative Site Recruiting
Nieuwegein, Netherlands, 3435 CM
Lucid Investigative Site Recruiting
Nijmegen, Netherlands, 6525 GA
Lucid Investigative Site Not yet recruiting
Rotterdam, Netherlands, 3015 GD
Sponsors and Collaborators
Lucid Diagnostics, Inc.
Investigators
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Study Director: Randy B, MS Lucid Diagnostics, Inc.
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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: July 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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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