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Recruiting Not applicable Interventional

Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance

ClinicalTrials.gov ID: NCT05530343

Public ClinicalTrials.gov record NCT05530343. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 7:41 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter Randomized Trial of Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance (The SWAT-BE Study)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this research study is to learn about the best approach to sample patients with known or suspected Barrett's esophagus (BE) by comparing the standard Seattle biopsy protocol to sampling using wide area transepithelial sampling (WATS3D). Barrett's esophagus is a common condition that is used to spot patients at increased risk of developing a type of cancer in the esophagus (swallowing tube) called esophageal adenocarcinoma. The 5-year survival rate is as low as 18% for patients who get esophageal adenocarcinoma, but the rate may be improved if the cancer is caught in its early stages. Barrett's esophagus can lead to dysplasia, or precancerous changes, which occurs when cells look abnormal but have not developed into cancer. If the abnormal cells increase from being slightly abnormal (low-grade dysplasia), to being very abnormal (high-grade dysplasia), the risk of developing cancer (esophageal adenocarcinoma) goes up. Therefore, catching dysplasia early is very important to prevent cancer. Endoscopic surveillance is a type of procedure where endoscopists run a tube with a light and a camera on the end of it down a patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells. Patients are being asked to be in this research study because they have been diagnosed with BE or suspected to have BE, and will need an esophagogastroduodenoscopy (EGD). Patients with BE undergo sampling using the Seattle biopsy protocol during which samples are obtained from the BE in a four quadrant fashion every 2 cm along with target biopsies from any abnormal areas within the BE. Another sampling approach is WATS3D which utilizes brushings from the BE. While both of these procedures are widely accepted approaches to sampling patients with BE during endoscopy, there is not enough research to show if one is better than the other. Participants in this study will undergo sampling of the BE using both approaches (Seattle biopsy protocol and WATS-3D); the order of the techniques will be randomized. Up to 2700 participants will take part in this research. This is a multicenter study involving several academic, community and private hospitals around the country.

Study identification

NCT ID
NCT05530343
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Enrollment
2,298 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 89 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2, 2022
Primary completion
May 31, 2026
Completion
May 31, 2026
Last update posted
Jun 30, 2026

2022 – 2026

United States locations

U.S. sites
14
U.S. states
11
U.S. cities
14
Facility City State ZIP Site status
Arizona Centers of Digestive Health Gilbert Arizona 85295 Recruiting
UCLA / Jonsson Comprehensive Cancer Center Los Angeles California 90024 Recruiting
Kaiser Permanente Oakland California 94611 Recruiting
University of Colorado Anschutz Medical Campus Aurora Colorado 80045 Recruiting
Connecticut Clinical Research Institute Bristol Connecticut 06010 Recruiting
Suncoast Endoscopy of Sarasota Sarasota Florida 34239 Recruiting
Northwestern University Chicago Illinois 60611 Recruiting
Mayo Clinic Rochester Minnesota 55905 Recruiting
Long Island Jewish Medical Center New Hyde Park New York 11040 Recruiting
Weill Cornell Medicine New York New York 10065 Recruiting
University of Rochester Rochester New York 14642 Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599 Recruiting
Geisinger Medical Center Danville Pennsylvania 17822 Recruiting
Gastrointestinal Associates, PC Knoxville Tennessee 37909 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05530343, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 30, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05530343 live on ClinicalTrials.gov.

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