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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
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Diagnostic yield of dysplasia (Surveillance population only)
Diagnostic yield of intestinal metaplasia (Screening population only)
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,820,579 Total Patients Enrolled
Sachin Wani, MDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus
9 Previous Clinical Trials
7,295 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am being monitored for Barrett's esophagus without severe cell changes.My doctor is trained and certified to use WATS3D for the study.I am being monitored or considered for treatment due to a previous diagnosis of Barrett's esophagus-related changes or esophageal cancer.I have enlarged veins in my esophagus.I have severe acid reflux damage in my esophagus.I have a history of endocrine therapy.I am being monitored or evaluated for esophageal issues due to a previous diagnosis.I can speak English and Spanish.I have had surgery on my esophagus or stomach, but it was not for a major issue.I am between 18 and 89 years old.My Barrett's esophagus is at least 1 cm long.
Research Study Groups:
This trial has the following groups:- Group 1: Seattle protocol, then WATS3D brushings.
- Group 2: WATS3D brushings, then Seattle Protocol.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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