← Back to Search

WATS-3D Tissue Sampling for Barrett's Esophagus Detection

N/A

Recruiting

Led By Srinadh Komanduri

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Patients who have achieved CE-IM on at least one surveillance endoscopy following EET

All patients aged 18+ diagnosed with Barrett's esophagus with confirmed histologic dysplasia or intra-mucosal cancer undergoing surveillance after EET

Must not have

Thrombocytopenia with platelets < 125,000 that cannot be corrected with blood products

Inability to pass standard endoscope

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a new technology called WATS-3D to see if it can help detect Barrett's esophagus recurrence following treatment.

Who is the study for?

This trial is for adults over 18 with Barrett's esophagus who've had previous treatment and are under surveillance. They must have shown some healing in a past check-up and be able to give informed consent. Pregnant individuals, prisoners, those with a life expectancy less than a year, severe blood platelet or clotting issues, or an inability to undergo endoscopy safely are excluded.

What is being tested?

The study tests if using WATS-3D tissue sampling before or after standard biopsies improves detection of recurrent Barrett's esophagus after treatment. This could lead to earlier re-treatment and prevention of progression to esophageal cancer.

What are the potential side effects?

While the document doesn't specify side effects, typical risks may include discomfort from the brush sampling procedure, bleeding due to biopsy collection, potential infection risk post-procedure, and rare complications related to endoscopy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have shown improvement in my esophagus condition after treatment.

Select...

I am 18 or older with Barrett's esophagus and have had early cancer or precancerous changes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My platelet count is below 125,000 and cannot be increased with treatment.

Select...

A standard endoscope cannot be used on me.

Select...

I cannot have an elective endoscopy due to my current health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess the additive diagnostic yield as assessed by proportion of patients with recurrence be use of WATS-3D

Secondary study objectives

To assess if the order by which tissue is sampled affects the diagnostic yield of WATS-3D by comparing the proportion of patients with recurrence between groups.

To assess if there is a difference in diagnostic yield of WATS-3D based on CE-IM definition between one and two or more endoscopies

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Post-EET Surveillance Group: WATS-3D samples followed by Forceps biopsiesActive Control1 Intervention

Sampling will occur with WATS-3D followed by forceps biopsies. For each patient, resection samples will be identified by the endoscopy method used to locate the sample as either HD-WLE/NBI or WATS-3D. For each method of detection, the highest grade of histology for each patient will be assigned based on the identified samples. Dysplasia detected on random biopsies will be attributed HD-WLE/NBI given it is part of the standard of care.

Group II: Post-EET Surveillance Group: Forceps biopsies followed by WATS-3D samplesActive Control1 Intervention

Sampling will occur with forceps biopsies followed by WATS-3D. For each patient, resection samples will be identified by the endoscopy method used to locate the sample as either HD-WLE/NBI or WATS-3D. For each method of detection, the highest grade of histology for each patient will be assigned based on the identified samples. Dysplasia detected on random biopsies will be attributed HD-WLE/NBI given it is part of the standard of care.

0 / 5Eligibility criteria met