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Procedure

WATS3D vs Seattle Protocol for Barrett's Esophagus (SWAT-BE Trial)

N/A

Recruiting

Led By Sachin Wani, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

SWAT-BE Trial Summary

This trial is being done to compare the two widely accepted approaches to sampling patients with Barrett's Esophagus to see which is more effective in spotting dysplasia early.

Who is the study for?

This trial is for English and Spanish speakers aged 18-89 with Barrett's esophagus (BE), specifically non-dysplastic BE or those previously diagnosed with low-grade dysplasia but now showing NDBE. Participants must have a life expectancy of at least 2 years, be able to consent, and are undergoing surveillance endoscopy. Excluded are individuals with severe erosive esophagitis, esophageal varices, history of certain surgeries, pregnancy, or previous high-grade dysplasia/esophageal cancer treatments.Check my eligibility

What is being tested?

The study compares two methods for sampling tissue in patients with Barrett's Esophagus: the standard Seattle biopsy protocol and WATS3D brushings. The goal is to determine which method is more effective at detecting precancerous changes early on. Each participant will experience both procedures in a randomized order during their scheduled endoscopic surveillance.See study design

What are the potential side effects?

Potential side effects from these procedures may include discomfort in the throat, risk of bleeding or infection from biopsies taken during endoscopy, and rare complications related to sedation such as allergic reactions or breathing difficulties.

SWAT-BE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Diagnostic yield of dysplasia (Surveillance population only)

Diagnostic yield of intestinal metaplasia (Screening population only)

Secondary outcome measures

Counts of participants with a biomarker or panel of biomarkers associated with increased risk of progression

Detection of intestinal metaplasia (Surveillance population only)

Diagnostic yield between the Seattle protocol and WATS3D Vs. the Seattle protocol alone (Surveillance population only)

+6 more

SWAT-BE Trial Design

2Treatment groups

Experimental Treatment

Group I: WATS3D brushings, then Seattle Protocol.Experimental Treatment2 Interventions

Participants in the screening or surveillance population that receive the WATS3D brushings, then the Seattle protocol, during the same procedure.

Group II: Seattle protocol, then WATS3D brushings.Experimental Treatment2 Interventions

Participants in the screening or surveillance population that receive the Seattle protocol, then WATS3D brushings, during the same procedure.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,146,826 Total Patients Enrolled

Sachin Wani, MDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus

8 Previous Clinical Trials

6,739 Total Patients Enrolled

Media Library

Seattle protocol (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05530343 — N/A

Barrett's Esophagus Research Study Groups: Seattle protocol, then WATS3D brushings., WATS3D brushings, then Seattle Protocol.

Barrett's Esophagus Clinical Trial 2023: Seattle protocol Highlights & Side Effects. Trial Name: NCT05530343 — N/A

Seattle protocol (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05530343 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary goal of this research endeavor?

"The primary metric of this trial, which is estimated to last up to 12 months, is the diagnostic yield of dysplasia for those in the Surveillance population. Amongst others, secondary objectives include identifying participants with a biomarker or panel associated with an elevated risk of progression and studying the proportion of positive results between Seattle protocol and WATS3D technique compared to just using the latter alone. Additionally, total sampling time will be measured across both protocols as well."

Answered by AI

Are there opportunities for new participants to join the experiment?

"According to the clinicaltrials.gov website, this trial is actively seeking participants since its inception on October 3rd 2022 and most recently updated November 29th 2022."

Answered by AI

How many participants will be accepted into this medical research program?

"This study necessitates the inclusion of 2700 individuals that meet specific requirements. Potential participants can join this trial at University of Colorado Anschutz Medical Campus in Aurora, Colorado and Long Island Jewish Medical Center in New Hyde Park, New york among other locations."

Answered by AI