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

Barrett Esophagus Clinical Trial

— ASBE  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778851
• Other study ID #: ASBE
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: Lucid Diagnostics, Inc.
• Contact: Victoria T Lee, MD
• Phone: 4252186535
• Email: VTL[@]pavmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

Device:
• EsoGuard result
Education slide-set EsoGuard and patient cases including EsoGuard result

Locations

Country	Name	City	State
United States	Lucid Diagnostics	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Lucid Diagnostics, Inc.	Medex15

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral	The change in the percentage/rate of virtual patient cases who will be referred for endoscopy in the intervention round compared to the control round.; The proportion of patient cases in round 2 for which the provider indicated that the EsoGuard result influenced his/her decision to refer the patient for upper endoscopy divided by all patient cases in round 2.	1 month
Secondary	The impact of EsoCheck/EsoGuard on health care provider's patient risk assessment for BE	The change in the provider's virtual patient risk assessment for BE in the intervention round compared to the control round.	1 month