Navicam for Detection of Barrett's Esophagus (NCT06748911) | Clinical Trial Compass
RecruitingNot Applicable
Navicam for Detection of Barrett's Esophagus
United States57 participantsStarted 2025-02-20
Plain-language summary
Using a non-invasive capsule system to achieve optimal viewing angles of the esophagus for detection of Barrett's esophagus
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Detection of Columnar lined epithelium in the esophagus
Timeframe: From start of procedure to removal of capsule, assessed up to 30 minutes timeframe from start to end of procedure..