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NCT06748911NARecruiting

Navicam for Detection of Barrett's Esophagus

Mayo Clinic

Start Date

2/20/2025

Completion Date

6/30/2026

Summary

Using a non-invasive capsule system to achieve optimal viewing angles of the esophagus for detection of Barrett's esophagus

Eligibility Criteria

Age Range: 22 years to No maximum

Inclusion Criteria * Adults greater than or equal to 22 years of age with or without Barrett's Esophagus * All Patients: o Have had an endoscopy within 1 year of baseline enrollment * Patients with Barrett's Esophagus: * Presence of at least 1cm of salmon colored mucosa with corresponding biopsies showing intestinal metaplasia who are treatment naïve and undergoing surveillance Or * Chronic Gastro Esophageal Reflux Disease (GERD) patients with at least 3 additional risk factors that meet Barrett's Esophagus screening criteria per latest clinical guidelines Exclusion Criteria * Inability to comprehend or read the consent form * Have an oropharynx, esophageal, or gastro-esophageal tumor * Ongoing symptoms of dysphagia * Presence of active clinically significant stricture * History of stricture requiring dilation * Presence of pacemaker or implanted cardiac defibrillator * History of esophageal surgery with the exception of fundoplication * Pregnancy * History of surgery or obstructive process of the small bowel * BMI \> 38

Interventions

DEVICE

NaviCam Detachable String Capsule

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Conditions

Barrett's Esophagus

Locations

Mayo Clinic in Florida

Jacksonville, Florida 32224

United States