Trial Outcomes & Findings for 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 (NCT NCT05778851)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

97 participants

Primary outcome timeframe

1 month

Results posted on

2025-10-30

Participant Flow

97 physicians (participant providers) signed an ICF.

A total of 90 providers completed the control round questionnaire with 6 control cases (total of 540 control cases) and a total of 87 completed the intervention round questionnaire with 6 cases (total of 522 intervention cases).

Unit of analysis: Cases

Participant milestones

Participant milestones
Measure	Participating Physicians Each participating physician completed 2 times a questionnaire with 6 virtual patient cases per provider with GERD, BE risk factors and without an EsoGuard result and with an EsoGuard result. With 90 participants the total in the control group is 540 control cases, and 87 participants completed the second questionnaire leading to 522 intervention cases.
Overall Study STARTED	90 540
Overall Study COMPLETED	87 522
Overall Study NOT COMPLETED	3 18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participating Physicians n=90 Participants Participating physicians could be primary care physicians or specialists.
Age, Categorical <=18 years	0 Participants n=90 Participants
Age, Categorical Between 18 and 65 years	90 Participants n=90 Participants
Age, Categorical >=65 years	0 Participants n=90 Participants
Physician type Primary Care	68 Participants n=90 Participants • Primary Care
Physician type Specialist	22 Participants n=90 Participants • Primary Care

PRIMARY outcome

Timeframe: 1 month

Population: A total of 540 control cases were reviewed by 90 providers, and a total of 522 intervention cases were reviewed by 87 providers.

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

Outcome measures

Outcome measures
Measure	Control Cases n=540 Cases Virtual patient cases without EsoGuard results	Intervention Cases n=522 Cases Virtual patient cases with EsoGuard results
The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral	382 Cases	211 Cases

SECONDARY outcome

Timeframe: 1 month

Population: A total of 90 EsoGuard + control cases were reviewed by 90 providers, and a total of 87 EsoGuard + intervention cases were reviewed by 87 providers.

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

Outcome measures

Outcome measures
Measure	Control Cases n=90 Cases Virtual patient cases without EsoGuard results	Intervention Cases n=87 Cases Virtual patient cases with EsoGuard results
The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral for EsoGuard Positive Cases	53 Cases	78 Cases

Adverse Events

Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Victoria T. Lee, MD CMO, SVM Clinical Affairs

PAVmed Inc., Lucid Diagnostics Inc.

Phone: 425.218.6535

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place