Navicam for Detection of Barrett's Esophagus

Last updated: April 7, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Barrett's Esophagus

Heartburn

Treatment

NaviCam Detachable String Capsule

Clinical Study ID

NCT06748911
24-000150
  • Ages > 22
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 57
Treatment Group(s): 1
Primary Treatment: NaviCam Detachable String Capsule
Phase:
Study Start date:
February 20, 2025
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

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