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Swallowable capsule and lab test take on endoscopy for esophageal cancer screening

NCT ID NCT04295811

NEW Diagnosis Sponsor: Lucid Diagnostics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are comparing a new approach for detecting Barrett's esophagus and esophageal adenocarcinoma against the standard method, endoscopy with biopsies. The new approach uses a capsule device called EsoCheck to collect cells from the esophagus, which are then analyzed with a lab test called EsoGuard. The study enrolls men aged 50 and older with a history of GERD symptoms or treatment, including both people already diagnosed with these conditions and those undergoing screening without a prior diagnosis. The goal is to see how well the capsule-based test detects disease across different stages compared to endoscopy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EsoGuard lab test on cells collected with the EsoCheck capsule device
What this could lead to
If it works, this could offer a less invasive way to screen for Barrett's esophagus and esophageal cancer, potentially replacing some endoscopies with a swallowable capsule and lab test.
What could go wrong
The test may miss cases that endoscopy would catch, or flag people who do not have the condition. This study compares the two approaches in a specific group, so results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

784 people

The number who actually took part.

Started

Jun 2020

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: All Patients: 1. Men aged 50 years and above 2. ≥5 years either of * Gastroesophageal Reflux Disease (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 3. No solid foods eaten for at least 2 hours prior to EsoCheck procedure 4. One or more of the following: * Caucasian race * Current or past history of cigarette smoking * Body mass index (BMI) of at least 30 kg/m2 * First-degree relative with Barrett's Esophagus (BE) or Esophageal Adenocarcinoma (EAC) Cases: 1. Previous diagnosis of non-dysplastic Barrett's Esophagus (NDBE), low grade dysplasia (LGD), high grade dysplasia (HGD), and/or intramucosal adenocarcinoma (IMC) 2. Diagnosis by esophagogastroduodenoscopy (EGD) (with exception of NDBE) was within 4 months prior to study enrollment 3. Indicated for surveillance EGD or for therapeutic EGD 4. Able to provide, by day of study EGD, the original glass slide(s) of biopsy specimens from most recent prior EGD Exclusion Criteria: 1. Inability to provide written informed consent 2. On anti-coagulant drug(s) that cannot be temporarily discontinued 3. Known history of esophageal varices or esophageal stricture 4. 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 5. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills 6. Oropharyngeal tumor 7. History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure 8. History of myocardial infarction or cerebrovascular accident within past 6 months 9. Any known lesion which, in the opinion of the endoscopist, obstructs greater than 25% of the esophageal lumen 10. Prior participation in PR-0139/EG-CL-101 (Lucid BE Screening Study) 11. Prior EGD during which a therapeutic procedure such as, but not limited to, ablation, cryotherapy or endoscopic mucosal resection, was performed for the treatment of BE and/or EAC 12. History of esophageal motility disorder 13. Currently implanted Linx device

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus Barrett esophagus esophageal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Barrett esophagus Barrett's esophagus without dysplasia Barretts esophagus with dysplasia Esophageal adenocarcinoma

Contacts and locations

Locations

  • Lucid Investigative Site

    Aurora, Colorado, 80045, United States

  • Lucid Investigative Site

    Englewood, Colorado, 80113, United States

  • Lucid Investigative Site

    Washington D.C., District of Columbia, 20007, United States

  • Lucid Investigative Site

    Jacksonville, Florida, 32256, United States

  • Lucid Investigative Site

    Chicago, Illinois, 60611, United States

  • Lucid Investigative Site

    Shreveport, Louisiana, 71105, United States

  • Lucid Investigative Site

    Baltimore, Maryland, 21287, United States

  • Lucid Investigative Site

    Boston, Massachusetts, 02215, United States

  • Lucid Investigative Site

    Ann Arbor, Michigan, 48109, United States

  • Lucid Investigative Site

    Flowood, Mississippi, 39232, United States

  • Lucid Investigative Site

    St Louis, Missouri, 63110, United States

  • Lucid Investigative Site

    Omaha, Nebraska, 68124, United States

  • Lucid Investigative Site

    Lebanon, New Hampshire, 03756, United States

  • Lucid Investigative Site

    New Hyde Park, New York, 11030, United States

  • Lucid Investigative Site

    Rochester, New York, 14620, United States

  • Lucid Investigative Site

    Chapel Hill, North Carolina, 27599, United States

  • Lucid Investigative Site

    Portland, Oregon, 97239, United States

  • Lucid Investigative Site

    Philadelphia, Pennsylvania, 19104, United States

  • Lucid Investigative Site

    Philadelphia, Pennsylvania, 19107, United States

  • Lucid Investigative Site

    Charleston, South Carolina, 29425, United States

  • Lucid Investigative Site

    Greenville, South Carolina, 29615, United States

  • Lucid Investigative Site

    Knoxville, Tennessee, 37909, United States

  • Lucid Investigative Site

    Nashville, Tennessee, 37212, United States

  • Lucid Investigative Site

    Austin, Texas, 78712, United States

  • Lucid Investigative Site

    Dallas, Texas, 75246, United States

  • Lucid Investigative Site

    Houston, Texas, 77030, United States

  • Lucid Investigative Site

    Salt Lake City, Utah, 84132, United States

  • Lucid Investigative Site

    Richmond, Virginia, 23249, United States

  • Lucid Investigative Site

    Richmond, Virginia, 23298, United States

  • Lucid Investigative Site

    Amsterdam, 1081 HZ, Netherlands

  • Lucid Investigative Site

    Eindhoven, 5623 EJ, Netherlands

  • Lucid Investigative Site

    Groningen, 9713 GZ, Netherlands

  • Lucid Investigative Site

    Nieuwegein, 3435 CM, Netherlands

  • Lucid Investigative Site

    Nijmegen, 6525 GA, Netherlands

  • Lucid Investigative Site

    Rotterdam, 3015 GD, Netherlands

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