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EsoCheck + EsoGuard for Barrett's Esophagus Screening (ASBE Trial)

N/A
Recruiting
Led By Victoria T Lee, MD
Research Sponsored by Lucid Diagnostics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

ASBE Trial Summary

This trial will compare healthcare provider decisions before & after being given EsoCheck/EsoGuard info; it'll measure how useful EsoCheck/EsoGuard is in helping docs decide if a patient needs endoscopy.

Who is the study for?
This trial is for board-certified physicians with 1-40 years of post-residency experience in fields like primary care, family medicine, gastroenterology, or foregut surgery. They must actively manage a large patient panel with over 50% adults.Check my eligibility
What is being tested?
The study tests the impact of EsoCheck/EsoGuard on doctors' decisions to refer patients for an upper endoscopy. It involves assessing patient cases before and after receiving educational material about these non-endoscopic screening tools.See study design
What are the potential side effects?
Since this trial focuses on physician decision-making rather than direct patient interventions, there are no side effects associated with EsoCheck/EsoGuard within the context of this study.

ASBE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral
Secondary outcome measures
The impact of EsoCheck/EsoGuard on health care provider's patient risk assessment for BE

ASBE Trial Design

6Treatment groups
Active Control
Group I: C2 InterventionActive Control1 Intervention
6 Virtual patient cases with GERD and similar BE risk factors as the cases in the control arm C1 with an EsoGuard result. 5 EsoGuard negative cases (same cases for all intervention questionnaires) and 1 positive EsoGuard case (different for questionnaire A/B/C).
Group II: A1 ControlActive Control1 Intervention
6 Virtual patient cases with GERD and similar BE risk factors as the cases in intervention arm A2 but without an EsoGuard result and in a different order.
Group III: A2 InterventionActive Control1 Intervention
6 Virtual patient cases with GERD and similar BE risk factors as the cases in the control arm A1 with an EsoGuard result. 5 EsoGuard negative cases (same cases for all intervention questionnaires) and 1 positive EsoGuard case (different for questionnaire A/B/C).
Group IV: B1 ControlActive Control1 Intervention
6 Virtual patient cases with GERD and similar BE risk factors as the cases in intervention arm B2 but without an EsoGuard result and in a different order.
Group V: B2 InterventionActive Control1 Intervention
6 Virtual patient cases with GERD and similar BE risk factors as the cases in the control arm B1 with an EsoGuard result. 5 EsoGuard negative cases (same cases for all intervention questionnaires) and 1 positive EsoGuard case (different for questionnaire A/B/C).
Group VI: C1 ControlActive Control1 Intervention
6 Virtual patient cases with GERD and similar BE risk factors as the cases in intervention arm C2 but without an EsoGuard result and in a different order.

Find a Location

Who is running the clinical trial?

Lucid Diagnostics, Inc.Lead Sponsor
5 Previous Clinical Trials
1,627 Total Patients Enrolled
Medex15Industry Sponsor
2 Previous Clinical Trials
315 Total Patients Enrolled
Victoria T Lee, MDPrincipal InvestigatorLucid Diagnostics

Media Library

C2 Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05778851 — N/A
Barrett's Esophagus Research Study Groups: C2 Intervention, A1 Control, A2 Intervention, B1 Control, B2 Intervention, C1 Control
Barrett's Esophagus Clinical Trial 2023: C2 Intervention Highlights & Side Effects. Trial Name: NCT05778851 — N/A
C2 Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05778851 — N/A
~48 spots leftby Jun 2025