Barrett EsophagusPR-0410NCT06030180
CLUE: CLinical Utility Study of EsoGuard
A study testing EsoGuard in people with Barrett Esophagus and Barretts Esophagus With Dysplasia, run by Lucid Diagnostics, Inc. at 8 sites in United States.
Trial summary
Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Barrett Esophagus, Barretts Esophagus With Dysplasia, Esophagus Adenocarcinoma
- What is being tested?
- EsoGuard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Feb 2023to 13 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals in whom the clinical decision has been made to screen for BE using EC/EG
- Individuals who meet criteria for BE screening in accordance with either the 2022 ACG guidelines, or the AGA best practice advice from their 2022 clinical practice update.
Who cannot join
- Individuals who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)
- Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE screening
- Inability to provide written informed consent or participate in the required follow up
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Arvada West Family Medicine,
Arvada, Colorado, 80004
James E Race
Dallas, Texas, 75224
Texas Digestive Specialists
Harlingen, Texas, 78550
Arkansas Heartburn Treatment Center
Heber Springs, Arkansas, 72543
Premier Family Medical
Lindon, Utah, 84042
Colorado Primary Healthcare
Littleton, Colorado, 80120
Savii Health
Savannah, Georgia, 31406
Gastroenterology Partners of North Houston, PLLC
Shenandoah, Texas, 77384
About this study
Official title: CLUE: CLinical Utility Study of EsoGuard on Samples Collected Using EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus (BE)
Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.
- Being tested
- EsoGuard
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsoGuardDevice
Also called EsoGuard test on cells collected using EsoCheck
EsoGuard is a set of genetic assays and algorithms for the assessment of specific methylation patterns of DNA encoding the genes vimentin (VIM) and cyclin A1 (CCNA1)
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Other | Not described Receives: Device: EsoGuard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Utility
Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. This will be measured by asking physicians how the EsoGuard result impacted their referral decision.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Patient Compliance
Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results. This will be measured by collecting data on whether patients received an endoscopy after being referred.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start23 Feb 2023
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucid Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gisella Lopez, Study director, Lucid Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030180
- Sponsor's protocol ID
- PR-0410
- Acronym
- PR-0410
- Status last verified
- Jun 2025
- First submitted
- 25 Aug 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLUE: CLinical Utility Study of EsoGuard on Samples Collected Using EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus (BE)
- ClinicalTrials.gov ID
- NCT06030180
- Acronym / sponsor ID
- PR-0410 / PR-0410
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Lucid Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Other | Device: EsoGuard |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals in whom the clinical decision has been made to screen for BE using EC/EG
- Individuals who meet criteria for BE screening in accordance with either the 2022 ACG guidelines, or the AGA best practice advice from their 2022 clinical practice update.
Key exclusion criteria (3 listed)
- Individuals who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)
- Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE screening
- Inability to provide written informed consent or participate in the required follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsoGuardAlso: EsoGuard test on cells collected using EsoCheckEsoGuard is a set of genetic assays and algorithms for the assessment of specific methylation patterns of DNA encoding the genes vimentin (VIM) and cyclin A1 (CCNA1) | Device | Single Arm Study |
Primary outcome
Clinical Utility
Time frame: Through study completion, an average of 1 year
Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. This will be measured by asking physicians how the EsoGuard result impacted their referral decision.
1 secondary outcome
Patient Compliance
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisella Lopez study director
Lucid Diagnostics
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EsoGuard in people with Barrett Esophagus and Barretts Esophagus With Dysplasia, run by Lucid Diagnostics, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Utility (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.