Barrett EsophagusESOGUARDBE1NCT04293458
Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE
A study testing EsoGuard in people with Barrett Esophagus and Esophageal Adenocarcinoma, run by Lucid Diagnostics, Inc. at 27 sites in 2 countries.
Trial summary
The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay on cells collected using the EsoCheck 510(k) cleared device, to detect Barrett's Esophagus, with and without dysplasia, and/or Esophageal Adenocarcinoma, in individuals deemed to be at high risk for these conditions… Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus, Esophageal Adenocarcinoma, Barretts Esophagus With Dysplasia
- What is being tested?
- EsoGuard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 28 Feb 2020to 22 Aug 2022
- 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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men aged 50 years old and older
- ≥5 years either of
- GERD symptoms,
- GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control is achieved or not), or,
- any combination of treated and untreated periods, as long the cumulative total is at least 5 years
- No solid foods eaten for at least 2 hours prior to EsoCheck procedure
Show all 12Show fewer
- One or more of the following risk factors:
- Caucasian race
- Current or past history of cigarette smoking
- BMI of at least 30 kg/m2
- First-degree relative with BE or EAC
- -
Who cannot join
- History of prior EGD procedure
- Inability to provide written informed consent
- On anti-coagulant drug(s) that cannot be temporarily discontinued
- Known history of esophageal varices or esophageal stricture
- Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
- History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
Show all 11Show fewer
- Oropharyngeal tumor
- History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
- History of myocardial infarction or cerebrovascular accident within past 6 months
- History of esophageal motility disorder
- Currently implanted Linx device
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States24 sites
Lucid Investigative Site
Chapel Hill, North Carolina, 27599
Lucid Investigative Site
Englewood, Colorado, 80113
Lucid Investigative Site
Flowood, Mississippi, 39232
Lucid Investigative Site
Greenville, South Carolina, 29615
Lucid Investigative Site
Houston, Texas, 77030
Lucid Investigative Site
Idaho Falls, Idaho, 83404
Lucid Investigative Site
Knoxville, Tennessee, 37909
Lucid Investigative Site
Macon, Georgia, 31201
Lucid Investigative Site
Naples, Florida, 34102
Lucid Investigative Site
Nashville, Tennessee, 37212
Lucid Investigative Site
New Orleans, Louisiana, 70112
Lucid Investigative Site
New York, New York, 10016
Lucid Investigative Site
Oklahoma City, Oklahoma, 73102
Lucid Investigative Site
Omaha, Nebraska, 68124
Lucid Investigative Site
Orange, California, 92868
Lucid Investigative Site
Palm Harbor, Florida, 34684
Lucid Investigative Site
Philadelphia, Pennsylvania, 19107
Lucid Investigative Site
Richmond, Virginia, 23249
Lucid Investigative Site
Richmond, Virginia, 23298
Lucid Investigative Site
Rochester, New York, 14620
Lucid Investigative Site
Rockford, Illinois, 61107
Lucid Investigative Site
Salt Lake City, Utah, 84132
Lucid Investigative Site
Shreveport, Louisiana, 71105
Lucid Investigative Site
Wyoming, Michigan, 49519
Spain3 sites
Lucid Investigative Site
Madrid, 28040
Lucid Investigative Site
Valladolid, 47012
Lucid Investigative Site
Zaragoza, 50009
About this study
Official title: A Multicenter, Single-Arm Study of the Efficacy of EsoGuard(TM) on Samples Collected Using EsoCheck(TM) Versus Esophagogastroduodenoscopy for the Diagnosis of Barrett's Esophagus in an At-Risk Screening Population
The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay on cells collected using the EsoCheck 510(k) cleared device, to detect Barrett's Esophagus, with and without dysplasia, and/or Esophageal Adenocarcinoma, in individuals deemed to be at high risk for these conditions (i.e., screening) per ACG guidelines.
Read the detailed description
This is a multicenter, single-arm study designed to assess the operating characteristics of the EsoGuard diagnostic assay performed on distal esophageal mucosal cells collected using the EsoCheck cell collection device, compared to the gold standard, for the screening of BE with and without dysplasia and for esophageal adenocarcinoma (EAC), in patients at high risk for BE and for whom a screening EGD is indicated according to ACG-established criteria.
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia
- 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
EsoGuard assay (LDT) will be used on cells collected using EsoCheck (510K cleared esophageal cell collection device) and compared to results of EGD plus biopsies (when taken)
| Study group | Role | What they receive |
|---|---|---|
| EsoCheck vs. EGD with or without biopsies | Experimental | All subjects will undergo both the EsoCheck (non-invasive esophageal cell sample collection) followed by EGD (with or without biopsies) Receives: Device: EsoGuard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy
The sensitivity and specificity of EsoGuard for the diagnosis of BE on samples collected using EsoCheck, wherein the definitive diagnosis of BE is made by concomitant EGD and biopsy.
Measured: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks
Secondary outcomes (1)
Secondary Efficacy
Negative predictive value (NPV) and positive predictive value (PPV), calculated for the observed prevalence and over a range of prevalences from 1 to 15%.
Measured: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start28 Feb 2020
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter, Single Arm
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucid Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle McDermott, Study director, Lucid Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293458
- Sponsor's protocol ID
- PR-0139 / EG-CL-101
- Acronym
- ESOGUARDBE1
- Status last verified
- Jan 2023
- First submitted
- 26 Feb 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Shaheen NJ, Othman MO, Taunk J, Chang KJ, Jaganmohan S, Yachimski PS, Fang JC, Spataro JS, Verma S, Lee VT, deGuzman BJ, Aklog L. Use of a Two-Gene Methylated DNA Biomarker Assay and Nonendoscopic Balloon for Detection of Barrett Esophagus Among High-Risk Individuals in a Screening Population. Am J Gastroenterol. 2024 Nov 26;120(7):1511-1520. doi: 10.14309/ajg.0000000000003238.
PubMed 39588974
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm Study of the Efficacy of EsoGuard(TM) on Samples Collected Using EsoCheck(TM) Versus Esophagogastroduodenoscopy for the Diagnosis of Barrett's Esophagus in an At-Risk Screening Population
- ClinicalTrials.gov ID
- NCT04293458
- Acronym / sponsor ID
- ESOGUARDBE1 / PR-0139 / EG-CL-101
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Lucid Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 3 Mar 2020 (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.
The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay on cells collected using the EsoCheck 510(k) cleared device, to detect Barrett's Esophagus, with and without dysplasia, and/or Esophageal Adenocarcinoma, in individuals deemed to be at high risk for these conditions (i.e., screening) per ACG guidelines.
Detailed description
This is a multicenter, single-arm study designed to assess the operating characteristics of the EsoGuard diagnostic assay performed on distal esophageal mucosal cells collected using the EsoCheck cell collection device, compared to the gold standard, for the screening of BE with and without dysplasia and for esophageal adenocarcinoma (EAC), in patients at high risk for BE and for whom a screening EGD is indicated according to ACG-established criteria.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter, Single Arm
| Arm | Type | Receives |
|---|---|---|
| EsoCheck vs. EGD with or without biopsies | Experimental | Device: EsoGuardAll subjects will undergo both the EsoCheck (non-invasive esophageal cell sample collection) followed by EGD (with or without biopsies) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men aged 50 years old and older
- ≥5 years either of
- No solid foods eaten for at least 2 hours prior to EsoCheck procedure
- One or more of the following risk factors:
- -
Key exclusion criteria (11 listed)
- History of prior EGD procedure
- Inability to provide written informed consent
- On anti-coagulant drug(s) that cannot be temporarily discontinued
- Known history of esophageal varices or esophageal stricture
- Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
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 |
|---|---|---|
| EsoGuardEsoGuard assay (LDT) will be used on cells collected using EsoCheck (510K cleared esophageal cell collection device) and compared to results of EGD plus biopsies (when taken) | Device | EsoCheck vs. EGD with or without biopsies |
Primary outcome
Primary Efficacy
Time frame: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks
The sensitivity and specificity of EsoGuard for the diagnosis of BE on samples collected using EsoCheck, wherein the definitive diagnosis of BE is made by concomitant EGD and biopsy.
1 secondary outcome
Secondary Efficacy
Time frame: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks
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 25 Jan 2023.
- Derived from this study: PubMed 39588974Shaheen NJ, Othman MO, Taunk J, Chang KJ, Jaganmohan S, Yachimski PS, Fang JC, Spataro JS, Verma S, Lee VT, deGuzman BJ, Aklog L. Use of a Two-Gene Methylated DNA Biomarker Assay and Nonendoscopic Balloon for Detection of Barrett Esophagus Among High-Risk Individuals in a Screening Population. Am J Gastroenterol. 2024 Nov 26;120(7):1511-1520. doi: 10.14309/ajg.0000000000003238.
- 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.
Michelle McDermott study director
Lucid Diagnostics
27 sites in 2 countries: 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 Esophageal Adenocarcinoma, run by Lucid Diagnostics, Inc. at 27 sites in 2 countries.
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 12 inclusion and 11 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 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Spain. 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?
Primary Efficacy (time frame: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293458, which also lists 1 linked publication.
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 25 Jan 2023.