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OpenTrials
Completed

NCT Number: NCT05778851

Clinical Utility of a Non Endoscopic Device EsoCheck and Biomarker EsoGuard as Alternative to Endoscopy for Screening for Barrett's Esophagus in At Risk Population

This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.

The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes).

After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucid Diagnostics

New York, 10017, United States

About this study

This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.

Around 200 US physicians will be asked to participate in this study and at least 100 will be enrolled. Physicians eligible for participation are those whose scope of practice includes preventative care and disease screening - namely screening of BE, such as primary care physicians, family medicine physicians, and general practitioners; physicians whose scope of practice include diagnosis and management of esophageal disease may also participate.

The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes). Per round, there will be 3 different questionnaires consisting of 6 clinical vignettes (A/B/C). Participants will be randomized to questionnaire A, B or C according to the randomization scheme. After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Board-certified physicians whose scope of practice includes preventative care and disease screening, and/or those whose scope of practice include diagnosis and management of esophageal disease (examples include but are not limited to primary care physicians/ general practitioners, family medicine physicians, gastroenterologists, and foregut surgeons);
  • Have between 1 to 40 years of post-residency clinical experience within their field of practice;
  • Have an active panel (whether as part of a group practice, or individually) of over 1000 patients with an adult patient load of more than 50%.

Exclusion criteria

  • None

Treatment and study plan

EsoGuard result

Device

Education slide-set EsoGuard and patient cases including EsoGuard result

Primary outcomes

  1. The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral

    Time frame: 1 month

    The change in the percentage/rate of intervention cases who will be referred for endoscopy compared to the control cases.

Secondary outcomes

  1. The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral for EsoGuard Positive Cases

    Time frame: 1 month

    The change in the percentage/rate of EsoGuard postive intervention cases who will be referred for endoscopy compared to the control cases.

Sponsors and collaborators

Lead sponsor

Lucid Diagnostics, Inc.

Industry

Collaborators

  • Medex15

Registry information

Official study title

Clinical Utility of a Non Endoscopic Device EsoCheck and Biomarker EsoGuard as Alternative to Endoscopy for Screening for Barrett's Esophagus in At Risk Population (ASBE) A Randomized Controlled, Virtual Patient Trial

Acronym: ASBE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 21, 2023
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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