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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
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral
Secondary study objectives
The impact of EsoCheck/EsoGuard on health care provider's patient risk assessment for BE
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Lucid Diagnostics, Inc.Lead Sponsor
6 Previous Clinical Trials
1,652 Total Patients Enrolled
Medex15Industry Sponsor
2 Previous Clinical Trials
315 Total Patients Enrolled
Victoria T Lee, MDPrincipal InvestigatorLucid Diagnostics
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have at least one year and no more than forty years of post-residency clinical experience in your field.You are a board-certified physician whose area of expertise encompasses preventive care, disease screening, diagnosis and management of esophageal diseases (such as primary care physicians/ general practitioners, family medicine physicians, gastroenterologists or foregut surgeons).You maintain a panel of at least 1000 patients, with adults comprising more than half.No specific criteria or restrictions apply.
Research Study Groups:
This trial has the following groups:- Group 1: C2 Intervention
- Group 2: A1 Control
- Group 3: A2 Intervention
- Group 4: B1 Control
- Group 5: B2 Intervention
- Group 6: C1 Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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