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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I have shown improvement in my esophagus condition after treatment.

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

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

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

Primary outcome measures

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

Secondary outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineOTHER

1,935 Previous Clinical Trials

2,299,610 Total Patients Enrolled

University of California, Los AngelesOTHER

1,530 Previous Clinical Trials

10,264,508 Total Patients Enrolled

University of Colorado, DenverOTHER

1,738 Previous Clinical Trials

2,149,326 Total Patients Enrolled

Media Library

Post-EET Surveillance Group: WATS-3D samples followed by Forceps biopsies Clinical Trial Eligibility Overview. Trial Name: NCT05056051 — N/A

Barrett's Esophagus Research Study Groups: Post-EET Surveillance Group: WATS-3D samples followed by Forceps biopsies, Post-EET Surveillance Group: Forceps biopsies followed by WATS-3D samples

Barrett's Esophagus Clinical Trial 2023: Post-EET Surveillance Group: WATS-3D samples followed by Forceps biopsies Highlights & Side Effects. Trial Name: NCT05056051 — N/A

Post-EET Surveillance Group: WATS-3D samples followed by Forceps biopsies 2023 Treatment Timeline for Medical Study. Trial Name: NCT05056051 — N/A

Frequently Asked Questions

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

Are there various venues offering this experiment?

"Patients in the Chicago area can enroll at Northwestern Memorial Hospital, whilst those near St. Louis have access to Washington University or Barnes Jewish Hospital. Likewise, individuals living around Aurora are able to join this trial through University of Colorado; additionally, 4 other medical sites also accept participants."

Answered by AI

Is this research endeavor currently accepting new participants?

"According to the clinicaltrials.gov database, this research project is actively seeking participants with its original postdate of October 1st 2020 and latest update on September 14th 2021."

Answered by AI

To what extent has the enrollment in this research endeavor progressed?

"This clinical trial necessitates 200 participants that meet the necessary qualifications. Patients may take part in this study at Northwestern Memorial Hospital (Chicago, IL), Washington University or Barnes Jewish Hospital (St Louis, MO)."

Answered by AI