RecruitingNot ApplicableNCT06748911

Navicam for Detection of Barrett's Esophagus

Use of a Detachable String Capsule for Evaluation of Barrett's Esophagus

Sponsor

Mayo Clinic

Enrollment

57 participants

Start Date

Feb 20, 2025

Study Type

INTERVENTIONAL

Conditions

Barrett's Esophagus

Summary

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

Eligibility

Min Age: 22 Years

Inclusion Criteria6

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 Criteria10

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

DEVICENaviCam Detachable String Capsule

Subjects will swallow the NaviCam capsule with 20 ml water while positioned in the upright position. Once the capsule reaches the gastric cardia, the string will slowly be pulled up to systematically inspect the Z-line and upper, middle, and lower thirds of the esophagus guided by real-time viewing and by moving the capsule solely with the tether. Images will be captured at a rate of 2 frames per second.