Tethered Capsule Endoscope in Screening Patients With Barrett Esophagus

Completed · Not applicable

Conditions studied: Barrett Esophagus

In brief

This pilot clinical trial studies how well tethered capsule endoscope works in screening patients with Barrett esophagus (BE), a condition where the lining of the esophagus has changed or has been replaced with abnormal cells that may lead to cancer also called esophageal cancer. In an attempt to prevent the progression from BE to esophageal cancer, patients undergo a standard procedure called esophagogastroduodenoscopy (EGD) where patients are sedated and the doctor uses an endoscope to examine the tissue in the esophagus. Tethered capsule endoscope is a tiny capsule with a laser scan inside and a very thin cord attached to it. Patients swallow the capsule and the thin cord keeps the capsule in specific area in the esophagus. After pictures of the lining of esophagus are taken, the capsule is removed using the thin cord. Tethered capsule endoscope may be able to identify tissue changes in patients with BE without the need for sedation or anesthesia, thus eliminating the associated risks and costs associated with EGD.

Key facts

Study ID

NCT02729948

Run by

University of Washington

People needed

1

Starts

2016-07-28

Expected to finish

2017-08-03

Last updated by the study team

2019-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability and willingness to provide written informed consent
• Scheduled for endoscopic screening and/or evaluation of Barrett's esophagus

You may not qualify if…

• Previous history of a swallowing disorder, such as scleroderma, achalasia, esophageal stricture or esophageal diverticulum
• Symptoms of dysphagia
• Suspicion or known history of gastrointestinal obstruction
• History of prior surgery on the oropharynx, neck, esophagus, or stomach
• Current diagnosis of cancer, unstable cardiovascular disease, end-stage liver or kidney disease, or other major medical illness
• Currently taking anticoagulant medications or clopidogrel
• Major physical disability which would prevent subject from transferring from a chair to a bed and sitting in an upright position
• Inability to abstain from taking anything by mouth for at least 6 hours
• Currently pregnant
• Expected to undergo magnetic resonance imaging (MRI) within two weeks following the study procedure

Where it is running

• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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