A Multicenter Clinical Validation Study of EsoGuard® on Samples Collected Using EsoCheck® for the Detection of Barrett*s Esophagus with and without Dysplasia, and/or Esophageal Adenocarcinoma, using Esophagogastroduodenoscopy as the Diagnostic Comparator

EsoCheck* Device Administration Training Phase:
1) Males and Females age 22 and over
2) No solid foods eaten for at least 2 hours prior to EsoCheck* procedure

Main Study Phase
All Patients:
-1) Men aged 50 years and above
2) >=5 years either of
o Gastroesophageal reflux disease (GERD) symptoms,
o GERD treated with proton pump inhibitor (PPI) therapy (whether symptom
control is achieved or not), or
o any combination of treated and untreated periods, as long the cumulative
total is at least 5 years
o First-degree relative with BE or EAC
3) No solid foods eaten for at least 2 hours prior to EsoCheck
procedure
4) One or more of the following:
o Caucasian race
o Current or past history of cigarette smoking
o Body mass index (BMI) of at least 30 kg/m2
o First-degree relative with BE or EAC

Additional Inclusion Criteria for Cases:
Previous diagnosis of indefinite for dysplasia (IFD), NDBE, LGD,HGD and/or IMC
1, Previous diagnose by EGD of:
a. NDBE at any time, or,
b.LGD, HGD, or IMC within 4 months prior to study enrollment unless it is
certain, at the time of enrollment, that a full set of biopsies per Seattle
Protocol will be taken during the Study EGD, including biopsy of the most
visually advanced lesion(s). In such a case, the EGD establishing entry
diagnosis of LGD, HGD or IMC diagnosis can have been made at any time prior to
enrollment.
2) Indicated for surveillance EGD or for therapeutic EGD
3) Able to provide the original glass slide(s) of biopsy specimens from most
recent prior EGD

EsoCheck* Device Administration Training Phase:
1) Inability to provide written informed consent
2) On anti-coagulant drug(s) that cannot be temporarily discontinued, (as
defined in study memo CO/EG-CL-102/2020/002 and provided as an appendix to this
protocol)
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) Known difficulty swallowing (dysphagia) or painful swallowing (odynophagia),
including swallowing pills, which in the opinion of the Investigator will
preclude succesfull swollowing of the EsoCheck capsule.
6) Anxiety, which in the opinion of the investigator will preclude successful
swallowing of the EsoCheck capsule
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) Any known lesion which, in the opinion of the endoscopist, obstructs
greater than 25% of the esophageal lumen
11) Prior participation in PR-0139/EG-CL-101 (Lucid BE Screening Study),
PR-1038/EG-CL-102 and/or the BETRNet study (NCT00288119).
12) 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.
13) History of esophageal motility disorder
14) Currently implanted Linx device

Main Study Phase:
1) Inability to provide written informed consent
2) On anti-coagulant drug(s) that cannot be temporarily discontinued, (as
defined in study memo CO/EG-CL-102/2020/002 and provided as an appendix to this
protocol)
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) Known difficulty swallowing (dysphagia) or painful swallowing (odynophagia),
including swallowing pills, which in the opinion of the Investigator will
preclude succesfull swollowing of the EsoCheck capsule.
6) Anxiety, which in the opinion of the investigator will preclude successful
swallowing of the EsoCheck capsule
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) Any known lesion which, in the opinion of the endoscopist, obstructs
greater than 25% of the esophageal lumen
11) Prior participation in PR-0139/EG-CL-101 (Lucid BE Screening Study)and/or
the BETRNet study (NCT00288119).
12) 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.
13) History of esophageal motility disorder
14) Currently implanted Linx device