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)

Lucid Diagnostics

Status: Completed

Conditions: Barrett Esophagus

Treatments: Device: EsoGuard result

Study type: Interventional

Funder types: Industry

Identifiers

NCT05778851

ASBE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 97 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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);
2. Have between 1 to 40 years of post-residency clinical experience within their field of practice;
3. 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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97 participants in 2 patient groups

Control

No Intervention group

Description:

Virtual patient cases with GERD and similar BE risk factors as the cases in intervention but without an EsoGuard result and in a different order.

Intervention

Active Comparator group

Description:

Virtual patient cases with GERD and similar BE risk factors as the cases in the control arm with an EsoGuard result.

Treatment:

Device: EsoGuard result