Recruiting

Testing a simple sponge device to detect Barrett's esophagus early

Plain-English translation of NCT03961945 on ClinicalTrials.gov ↗ · Source last updated January 2026 · Translation generated August 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing a new way to detect Barrett's esophagus—a condition where the lining of your esophagus (food pipe) changes due to chronic acid reflux. Researchers are using a device called a "sponge on a string" that you swallow; it collects cells from your esophagus and is then pulled back up. The cells are then tested for special DNA markers that can show whether Barrett's esophagus or early cancer changes are present. This could be a simpler, less invasive alternative to traditional endoscopy.

Barrett's esophagus can develop into esophageal cancer if not caught early, but current screening methods require an invasive procedure (endoscopy). This trial aims to develop an easier, safer way to screen people at risk—one that could be done in an office by a nurse rather than requiring a specialist.

Do you qualify?

You likely qualify if…

you are between 50 and 85 years old (or 18–90 if you already have known or suspected Barrett's esophagus)
you have chronic acid reflux or have taken acid-reducing medications for at least 3 months in the past 5 years
you have three or more risk factors for Barrett's esophagus, such as being overweight (BMI ≥ 30)
you are scheduled for an upper endoscopy or willing to undergo the sponge procedure
you have not had an endoscopy in the past 5 years (for screening arm only)

You likely don't qualify if…

you have a history of esophageal cancer, esophageal surgery, or Barrett's esophagus with prior ablation treatment
you are currently taking blood thinners like Warfarin, Coumadin, or certain newer anticoagulants (unless you can stop them 3–5 days before the procedure)
you have a history of cirrhosis, bleeding disorders, or esophageal varices
you are pregnant or breastfeeding
you have a history of eosinophilic esophagitis or achalasia

What participation looks like

If you qualify, you will swallow the sponge-on-a-string device in a clinic or office setting—a nurse or non-physician staff member will guide you. The device collects cell samples from your esophagus and is then gently pulled back out. You may also complete questionnaires about your health. If you are already scheduled for endoscopy, you will undergo both the sponge procedure and routine endoscopic biopsies. The entire visit typically takes less than an hour, and there is no sedation required for the sponge procedure itself.

AI-generated summary from trial data · Aug 2, 2026 · Not medical advice

Trial locations(9 sites)

United States

Mayo Clinic Arizona, Scottsdale, Arizona

Mayo Clinic Jacksonville, Jacksonville, Florida

Mayo Clinic Health Systems - Austin, Austin, Minnesota

Mayo Clinic Health Systems - Mankato, Mankato, Minnesota

Mayo Clinic Rochester, Rochester, Minnesota