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Sponge Capsule Diagnosis for Esophageal Cancer

N/A

Recruiting

Led By Prasad G. Iyer, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Patients who have three or more risk factors for Barrett's Esophagus.

Male and female ages 50-85

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a newdevice to see if it can accurately detect Barrett's Esophagus and dysplasia/adenocarcinoma in people with or without GERD.

Who is the study for?

This trial is for men and women aged 50-85 who are primary care patients at Mayo Clinic Rochester or its Health Systems. It's specifically for those with three or more risk factors for Barrett's Esophagus, which often includes chronic acid reflux.

What is being tested?

The study is testing a sponge capsule device to see if it can accurately detect Barrett's Esophagus and any early signs of esophageal cancer in people, particularly among those with long-term gastroesophageal reflux disease.

What are the potential side effects?

Potential side effects from the sponge capsule procedure may include discomfort during swallowing, gagging, throat irritation, or minor bleeding. However, these are typically mild and temporary.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have three or more risk factors for Barrett's Esophagus.

Select...

I am between 50 and 85 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Aim 1 - Screening Population

Aim 2 - Case/Control Population BE Detection

Aim 3 - Dysplasia Detection Sensitivity and Specificity

Secondary study objectives

Aim 1 - Screening Population Predictive Value

Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure

Aim 2 - Case/Control Population Sensitivity and Specificity

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Upper endoscopy - No Barrett's EsophagusExperimental Treatment1 Intervention

Those that have no known Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.

Group II: Upper endoscopy - Barrett's EsophagusExperimental Treatment1 Intervention

Those that have a diagnosis of Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.

Group III: Screening PopulationExperimental Treatment1 Intervention

Those that have gastroesophageal reflux or other risk factors for Barrett's Esophagus will be contacted and if agreeable undergo sponge capsule procedure and fill out questionnaires.

0 / 2Eligibility criteria met