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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - All patients aged 18+ diagnosed with Barrett's esophagus with confirmed histologic dysplasia or intra-mucosal cancer undergoing surveillance after EET - Patients who have achieved CE-IM on at least one surveillance endoscopy following EET - All subjects must have given signed, willing to sign a consent form prior to registration in the study Who Should NOT Join This Trial: - All patients who are unable or unwilling to give consent will not be included in the study - All patients deemed to have refractory BE despite EET - Patients who are pregnant, vulnerable populations such as prisoners, life expectancy \< 1 year based on concurrent comorbidities, coagulopathy with INR \> 1.5 that cannot be reversed, thrombocytopenia with platelets \< 125,000 that cannot be corrected with blood products, unable to safely undergo elective endoscopy due to current comorbidities, and inability to pass standard endoscope will not be included in the study Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * All patients aged 18+ diagnosed with Barrett's esophagus with confirmed histologic dysplasia or intra-mucosal cancer undergoing surveillance after EET * Patients who have achieved CE-IM on at least one surveillance endoscopy following EET * All subjects must have given signed, informed consent prior to registration in the study Exclusion Criteria: * All patients who are unable or unwilling to give consent will not be included in the study * All patients deemed to have refractory BE despite EET * Patients who are pregnant, vulnerable populations such as prisoners, life expectancy \< 1 year based on concurrent comorbidities, coagulopathy with INR \> 1.5 that cannot be reversed, thrombocytopenia with platelets \< 125,000 that cannot be corrected with blood products, unable to safely undergo elective endoscopy due to current comorbidities, and inability to pass standard endoscope will not be included in the study

Treatments Being Tested

DEVICE

WATS-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.

DEVICE

WATS-3D tissue sampling following 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. This will be done after forceps biopsies in this arm.

Locations (4)

University of California, LA
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Washington University in St. Louis, Barnes Jewish Hospital
St Louis, Missouri, United States