Status:
UNKNOWN
Efficacy of EsoGuard Assay on Esophageal Surface Cells Collected With EsoCheck vs EGD for the Diagnosis of BE or EAC
Lead Sponsor:
Lucid Diagnostics, Inc.
Conditions:
Barrett Esophagus
Esophageal Adenocarcinoma
Eligibility:
MALE
50+ years
Phase:
NA
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 E...
Detailed Description
This is a two phase multicenter study to assess the operating characteristics of the EsoGuard diagnostic assay panel performed on esophageal mucosal cells collected using the EsoCheck cell collection ...
Eligibility Criteria
Inclusion
- 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 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:
- 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
- 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
- History of esophageal motility disorder
- Currently implanted Linx device
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT04295811
Start Date
June 18 2020
End Date
December 1 2023
Last Update
January 25 2023
Active Locations (38)
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1
Lucid Investigative Site
Birmingham, Alabama, United States, 35294
2
Lucid Investigative Site
Orange, California, United States, 92868
3
Lucid Investigative Site
Aurora, Colorado, United States, 80045
4
Lucid Investigative Site
Englewood, Colorado, United States, 80113