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WATS-3D Sampling for Barrett's Esophagus Recurrence

This study is looking at a new way to detect if Barrett's esophagus (a pre-cancerous condition that can lead to esophageal cancer) has returned after treatment. The study uses a technique called Wide-Area Transepithelial Sampling (WATS-3D), which involves brushing a large area of the esophagus to collect cells. This method samples much more tissue than standard biopsies. Researchers want to see if WATS-3D, when used either before or after standard biopsies, can better find recurrence of Barrett's esophagus. You may be able to join if you are 18 or older, have been diagnosed with Barrett's esophagus with dysplasia (abnormal cell growth) or early cancer, and have already had treatment that successfully cleared the condition. The study aims to enroll 200 participants to see how well WATS-3D helps find recurrence over two years.

Study design
This interventional study plans to enroll 200 participants to compare WATS-3D tissue sampling with standard biopsies.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will assess the diagnostic yield of WATS-3D over a period of two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05056051

Wide-Area Transepithelial Sampling in Endoscopic Eradication Therapy for Barrett's Esophagus

UNKNOWN
NAAges 18+InterventionalDiagnostic
Northwestern University
~200 participants
Updated 2024-04-24 on ClinicalTrials.gov
What's tested:WATS-3D tissue sampling prior to forceps biopsiesWATS-3D tissue sampling following forceps biopsies

At a glance

Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the additive diagnostic yield as assessed by proportion of patients with recurrence be use of WATS-3D
Measured over 2 years

Conditions

Barrett Esophagus
Esophageal Cancer

Explore related trials

Barrett EsophagusEsophageal Carcinoma

NCT05056051

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Northwestern Memorial Hospital

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • University of California, LA

    Los Angeles, Californiastudy coordinator listed

    Not yet recruiting

  • University of Colorado

    Aurora, Coloradostudy coordinator listed

    Not yet recruiting

  • Washington University in St. Louis, Barnes Jewish Hospital

    St Louis, Missouristudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Srinadh Komanduri · PRINCIPAL_INVESTIGATOR · Feinberg School of Medicine

Who to contact

Srinadh Komanduri, MD, MS
[email protected]
3126950484
Email the study team

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Eligibility criteria

Inclusion

All patients aged 18+ diagnosed with Barrett's esophagus with confirmed histologic dysplasia or intra-mucosal cancer undergoing surveillance after EET
Patients who have achieved CE-IM on at least one surveillance endoscopy following EET
All subjects must have given signed, informed consent prior to registration in the study

Exclusion

All patients who are unable or unwilling to give consent will not be included in the study
All patients deemed to have refractory BE despite EET
Patients who are pregnant, vulnerable populations such as prisoners, life expectancy \< 1 year based on concurrent comorbidities, coagulopathy with INR \> 1.5 that cannot be reversed, thrombocytopenia with platelets \< 125,000 that cannot be corrected with blood products, unable to safely undergo elective endoscopy due to current comorbidities, and inability to pass standard endoscope will not be included in the study

What this trial measures

  • To assess the additive diagnostic yield as assessed by proportion of patients with recurrence be use of WATS-3D2 years

    To assess the additive diagnostic yield of WATS-3D sampling beyond that of standard biopsies for detection of IM or dysplasia (recurrence) in patients who have undergone EET for BE-related neoplasia. The rates of recurrence as determined by the proportion of patients (percentage) deemed to have recurrence of BE on tissue sampling will be compared between samples obtained by WATS-3D vs forceps biopsies.