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EsoCheck + EsoGuard for Barrett's Esophagus and Esophageal Adenocarcinoma (ESOGUARDBE2 Trial)
N/A
Recruiting
Research Sponsored by Lucid Diagnostics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up per subject through study completion which is up to approximately 5 weeks
Awards & highlights
ESOGUARDBE2 Trial Summary
This trial will compare a new BE/EAC detection system to the current standard of care.
Eligible Conditions
- Esophageal Cancer
- Barrett's Esophagus
ESOGUARDBE2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ per subject through study completion which is up to approximately 5 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~per subject through study completion which is up to approximately 5 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Efficacy
Secondary outcome measures
Secondary Efficacy
Other outcome measures
Safety outcome of EsoCheck Device (510k cleared, non-invasive, esophageal cell collection device) on all patients who undergo the device procedure.
ESOGUARDBE2 Trial Design
1Treatment groups
Experimental Treatment
Group I: EsoCheck and EsoGuard vs. EGD with or without biopsiesExperimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esophagogastroduodenoscopy
2017
Completed Phase 3
~980
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Who is running the clinical trial?
Lucid Diagnostics, Inc.Lead Sponsor
5 Previous Clinical Trials
1,257 Total Patients Enrolled
Randy B, MSStudy DirectorLucid Diagnostics, Inc.
Michelle McDermottStudy DirectorLucid Diagnostics, Inc.
1 Previous Clinical Trials
145 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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