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
Conditions
Barrett's Esophagus
Locations
Mayo Clinic in Florida
Jacksonville, Florida 32224
United States