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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)

Primary Purpose

Barrett Esophagus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EsoGuard result
Sponsored by
Lucid Diagnostics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Barrett Esophagus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lucid DiagnosticsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

Active Comparator

No Intervention

Active Comparator

No Intervention

Active Comparator

Arm Label

A1 Control

A2 Intervention

B1 Control

B2 Intervention

C1 Control

C2 Intervention

Arm Description

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.

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).

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.

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).

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 10, 2023
Last Updated
October 9, 2023
Sponsor
Lucid Diagnostics, Inc.
Collaborators
Medex15
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1. Study Identification

Unique Protocol Identification Number
NCT05778851
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lucid Diagnostics, Inc.
Collaborators
Medex15

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A1 Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
A2 Intervention
Arm Type
Active Comparator
Arm Description
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).
Arm Title
B1 Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
B2 Intervention
Arm Type
Active Comparator
Arm Description
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).
Arm Title
C1 Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
C2 Intervention
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
EsoGuard result
Intervention Description
Education slide-set EsoGuard and patient cases including EsoGuard result
Primary Outcome Measure Information:
Title
The impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
The impact of EsoCheck/EsoGuard on health care provider's patient risk assessment for BE
Description
The change in the provider's virtual patient risk assessment for BE in the intervention round compared to the control round.
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria T Lee, MD
Phone
4252186535
Email
VTL@pavmed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lisette Stork, MSc
Email
lstork@medex15.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria T Lee, MD
Organizational Affiliation
Lucid Diagnostics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucid Diagnostics
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria T Lee, MD
Phone
425-218-6535
Email
VTL@pavmed.com

12. IPD Sharing Statement

Learn more about this trial

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

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