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Trial record 3 of 4 for:    esocheck

Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE (ESOGUARDBE1)

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ClinicalTrials.gov Identifier: NCT04293458
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
PAVmed Inc. ( Lucid Diagnostics, Inc. )

Tracking Information
First Submitted Date  ICMJE February 26, 2020
First Posted Date  ICMJE March 3, 2020
Last Update Posted Date July 23, 2021
Actual Study Start Date  ICMJE February 28, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2020)
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%.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 29, 2020)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE
Official Title  ICMJE 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
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.
Detailed Description 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Multicenter, Single Arm
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Barrett Esophagus
  • Esophageal Adenocarcinoma
  • Barretts Esophagus With Dysplasia
  • Barrett's Esophagus Without Dysplasia
Intervention  ICMJE 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)
Study Arms  ICMJE 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)
Intervention: Device: EsoGuard
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 29, 2020)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

    1. Caucasian race
    2. Current or past history of cigarette smoking
    3. BMI of at least 30 kg/m2
    4. First-degree relative with BE or EAC

      -

Exclusion Criteria:

  1. History of prior EGD procedure
  2. Inability to provide written informed consent
  3. On anti-coagulant drug(s) that cannot be temporarily discontinued
  4. Known history of esophageal varices or esophageal stricture
  5. 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
  6. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
  7. Oropharyngeal tumor
  8. History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
  9. History of myocardial infarction or cerebrovascular accident within past 6 months
  10. History of esophageal motility disorder
  11. Currently implanted Linx device
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Randy Brown 212-949-4319 RWB@LucidDx.com
Contact: Lisa Gott LLG@lucidDX.com
Listed Location Countries  ICMJE Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04293458
Other Study ID Numbers  ICMJE PR-0139 / EG-CL-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PAVmed Inc. ( Lucid Diagnostics, Inc. )
Study Sponsor  ICMJE Lucid Diagnostics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Randy Brown, MS Lucid Diagnostics
PRS Account PAVmed Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP