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Comparing Biopsy Methods for Barrett's Esophagus Surveillance

This study is comparing two ways to take samples (biopsies) from your esophagus (swallowing tube) if you have Barrett's esophagus. The goal is to see which method, the standard Seattle protocol or WATS3D brushings, is better at finding dysplasia (pre-cancerous changes) or intestinal metaplasia (a change in cells that can lead to Barrett's). Barrett's esophagus can increase your risk of esophageal adenocarcinoma, a type of cancer. The study will enroll about 2298 participants aged 18 to 89 who have Barrett's esophagus or are being screened for it. The study is looking for the diagnostic yield (how well each method finds these changes) within one year.

Study design
This is a multicenter randomized controlled trial, meaning participants are randomly assigned to receive one biopsy method first, then the other. The study plans to enroll about 2298 participants.
What's involved
You will undergo an upper endoscopy procedure where biopsies are taken using both the Seattle protocol and WATS3D brushings. The study measures outcomes up to one year.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for diagnostic yield are measured at up to one year.

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NCT05530343

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

Recruiting
NAAges 18–89InterventionalScreening
University of Colorado, Denver
~2,298 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Seattle protocolWATS3D brushings

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic yield of dysplasia (Surveillance population only)
Measured over up to 1 year
+1 more outcome measured

Conditions

Barrett Esophagus
Barretts Esophagus With Dysplasia
Esophageal Adenocarcinoma

Explore related trials

Barrett EsophagusDysplasiaEsophageal Adenocarcinoma

Where it's being run

14 sites across 11 states
New York3
California2
Arizona1
Colorado1
Connecticut1
Florida1
Illinois1
Minnesota1

Study leadership

  • Sachin Wani, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Alexa R DeBord, MS
[email protected]
303-724-0432
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Undergoing surveillance endoscopy for a diagnosis of non-dysplastic Barrett's esophagus (NDBE, based on last endoscopic procedure; patients with prior history of low-grade dysplasia/indefinite for dysplasia with NDBE at last endoscopy can be included)
Barrett's esophagus (BE) length of at least M1
English and Spanish speaking
Able to comprehend and complete the consent form
Age18-89 years
Life-expectancy of at least 2 years
Undergoing endoscopy for screening of BE
BE length of at least M1
English and Spanish speaking
Able to comprehend and complete the consent form
Age 18-89 years
Expected life-expectancy of at least 2 years
All participating sites will include physicians who are trained in the use of WATS3D and certified by the site PI. All endoscopists will need to complete a minimum of three cases to be eligible to participate in the study.

Exclusion

BE patients undergoing surveillance or evaluation for endoscopic eradication therapy (EET) for prior diagnosis of BE related dysplasia or esophageal adenocarcinoma (EAC)
Active erosive esophagitis with LA Grade B or higher
Esophageal varices
Prior history of EET
Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication
Pregnancy
BE patients undergoing surveillance or evaluation for EET for prior diagnosis for BE-related dysplasia or EAC
Active erosive esophagitis with LA Grade B or higher
Esophageal varices
Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication
Pregnancy

What this trial measures

  • Diagnostic yield of dysplasia (Surveillance population only)up to 1 year

    Proportion of positive results between the Seattle protocol and WATS3D technique. Positive results include low-grade dysplasia (LGD), high-grade dysplasia (HGD), and esophageal adenocarcinoma (EAC). All positive results for dysplasia or EAC with WATS3D sampling not detected on Seattle biopsy protocol at index endoscopy will require confirmation by repeat sampling using the Seattle biopsy protocol.

  • Diagnostic yield of intestinal metaplasia (Screening population only)up to 1 year

    Proportion of positive results between the Seattle protocol and WATS3D technique. Positive results include intestinal metaplasia. All positive results for intestinal metaplasia/dysplasia or esophageal adenocarcinoma (EAC) with WATS3D sampling not detected on Seattle biopsy protocol at index endoscopy will require confirmation by repeat sampling using the Seattle biopsy protocol.