RecruitingNot ApplicableNCT05056051

Wide-Area Transepithelial Sampling in Endoscopic Eradication Therapy for Barrett's Esophagus

Additive Value of Wide-Area Transepithelial Sampling (WATS3D) in Detection of Recurrence of Intestinal Metaplasia Following Endoscopic Eradication Therapy (EET) for Barrett's Esophagus-Related Neoplasia

Sponsor

Northwestern University

Enrollment

200 participants

Start Date

Oct 1, 2020

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Barrett Esophagus

Summary

Esophageal cancer is a deadly disease that is becoming increasingly common in the United States. Barrett's esophagus (BE) is a pre-cancerous state that can develop into esophageal cancer, but is highly treatable. Progression of BE to esophageal cancer is still common due to missed diagnosis of Barrett's esophagus recurrence following treatment. Wide-Area Trans-Epithelial Sampling (WATS-3D) is a new technology that uses brush sampling to examine larger areas of the esophagus as compared to conventional biopsies. Preliminary studies show improved detection of cancerous changes in Barrett's esophagus surveillance. The investigators hope to see if the addition of WATS-3D increases the rate of detection of recurrent BE following treatment, which is of the utmost importance since it would allow for earlier re-treatment of disease and ultimately allow for prevention of progression to esophageal cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new tissue sampling technique (wide-area transepithelial sampling, or WATS) for monitoring Barrett's esophagus — a condition where the lining of the esophagus changes due to acid reflux — after it has been treated with ablation therapy. The goal is to see if this technique can detect any remaining or recurrent abnormal cells more reliably. **You may be eligible if...** - You are 18 or older with a confirmed history of Barrett's esophagus with abnormal cells or early cancer - You have undergone endoscopic eradication therapy (EET) and achieved successful clearance on at least one surveillance scope - You have given signed consent **You may NOT be eligible if...** - You are pregnant - Your Barrett's esophagus did not respond to treatment - You have serious blood clotting problems - You are a prisoner or your life expectancy is less than 1 year due to other illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEWATS-3D tissue sampling prior to forceps biopsies

WATS-3D is a brush-based tissue sampling technique. Abrasive brush sampling of large areas of the esophagus pick up cells to obtain trans-epithelial specimens. This technique samples much larger tissue areas than standard forceps biopsies. Analysis is then done by proprietary neural-network based computer scanning and molecular diagnostics to identify abnormal cells.

DEVICEWATS-3D tissue sampling following forceps biopsies