Navicam for Detection of Barrett's Esophagus (DS-MCE-BE)

Mayo Clinic

Status: Enrolling

Conditions: Barrett's Esophagus

Treatments: Device: NaviCam Detachable String Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06748911

24-000150

Details and patient eligibility

About

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

Enrollment: 57 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 3 patient groups

Long Segment Barrett's Esophagus (LSBE)

Experimental group

Description:

Subjects diagnosed with Long Segment Barrett's Esophagus (LSBE)

Treatment:

Device: NaviCam Detachable String Capsule

Short Segment Barrett's Esophagus (SSBE)

Experimental group

Description:

Subjects diagnosed with Short Segment Barrett's Esophagus (SSBE)

Treatment:

Device: NaviCam Detachable String Capsule

Gastro Esophageal Reflux Disease

Experimental group

Description:

Subjects with Gastro Esophageal Reflux Disease (GERD) who are eligible for Barrett's Esophagus screening

Treatment:

Device: NaviCam Detachable String Capsule