RecruitingNot ApplicableNCT03961945

Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma


Sponsor

Mayo Clinic

Enrollment

1,550 participants

Start Date

Jul 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring less invasive ways — such as a swallowable capsule sponge — to detect Barrett's esophagus and esophageal cancer, as an alternative to traditional endoscopy. **You may be eligible if...** - You are age 50–85 with three or more risk factors for Barrett's esophagus, including acid reflux, obesity (BMI 30+), or long-term acid-reducing medication use (Aim 1) - OR you are age 18–90 with a known or suspected Barrett's esophagus segment of at least 1 cm and are scheduled for a routine endoscopy (Aim 2 and 3) - OR you are having a clinically indicated endoscopy without known Barrett's (as a comparison group) **You may NOT be eligible if...** - You have a history of esophageal cancer, prior ablation therapy for Barrett's, esophageal varices, or cirrhosis - You take blood thinners like Warfarin - You have had an endoscopy within the past 5 years (for Aim 1) - You have active Barrett's esophagus with a history of ablation (for Aim 2) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESponge Capsule

Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.


Locations(9)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Mayo Clinic Health Systems - Austin

Austin, Minnesota, United States

Mayo Clinic Health Systems - Mankato

Mankato, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Northwell Health

New Hyde Park, New York, United States

Baylor Scott & White Research Institute

Dallas, Texas, United States

Mayo Clinic Health System-Eau Claire

Eau Claire, Wisconsin, United States

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT03961945


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