A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus

Completed · Not applicable

Conditions studied: Barrett Esophagus

In brief

This study is being done to collect data on the potential use of a sponge on a string device as a non-invasive tool in evaluating patients with Barrett's Esophagus compared to healthy controls.

Key facts

Study ID

NCT02560623

Run by

Mayo Clinic

People needed

242

Starts

2015-10-15

Expected to finish

2021-07-08

Last updated by the study team

2022-11-17

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects with known Barrett's Esophagus (BE).
• Patients with a BE segment ≥ 1cm in maximal extent endoscopically.
• Histology showing evidence of intestinal metaplasia with or without presence of dysplasia.
• Undergoing clinically indicated endoscopy. Subjects without known evidence of BE - Undergoing clinically indicated diagnostic endoscopy

You may not qualify if…

• Subjects with known BE.
• Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection alone will not be excluded.
• Patients with history of esophageal resection for esophageal carcinoma. Subjects with or without known evidence of BE (on history or review of medical records).
• Pregnant or lactating females.
• Patients who are unable to consent.
• Patients with current history of eosinophilic esophagitis, achalasia or uninvestigated dysphagia.
• Patients on oral anticoagulation including Coumadin, Warfarin.
• Patients on antiplatelet agents including Clopidogrel, unless discontinued for 3 days prior to the sponge procedure.
• Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for 3 days prior to the sponge procedure.
• Patients with history of known varices or cirrhosis.
• Patients with history of esophageal resection for esophageal carcinoma.
• Patients with congenital or acquired bleeding diatheses.
• Patients with a history of esophageal squamous dysplasia.
• Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Mayo Clinic Health System - Mankato — Mankato, Minnesota, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Northwell Health — Manhasset, New York, United States
• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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