Navicam for Detection of Barrett's Esophagus

NCT06748911 | Recruiting FDA Device

• 1 other identifier: 24-000150
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Barrett's Esophagus

Outcome Measures

Primary Outcomes (1)

• Detection of Columnar lined epithelium in the esophagus

  Detection of Columnar lined epithelium in the esophagus

  From start of procedure to removal of capsule, assessed up to 30 minutes timeframe from start to end of procedure..

Secondary Outcomes (3)

• Visual Analogue Scale (VAS)

  30 minutes post-procedure

• Spielberger State-Trait Anxiety Inventory (STAI-6)

  Baseline, 30 minutes post-procedure

• Impact of Events Scale (IES)

  Baseline, 7 days post-procedure

Study Arms (3)

Long Segment Barrett's Esophagus (LSBE)

EXPERIMENTAL

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

Device: NaviCam Detachable String Capsule

Short Segment Barrett's Esophagus (SSBE)

EXPERIMENTAL

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

Device: NaviCam Detachable String Capsule

Gastro Esophageal Reflux Disease

EXPERIMENTAL

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

Device: NaviCam Detachable String Capsule

Interventions

NaviCam Detachable String Capsule DEVICE

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.

Gastro Esophageal Reflux Disease; Long Segment Barrett's Esophagus (LSBE); Short Segment Barrett's Esophagus (SSBE)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Swathi Eluri

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie McNew

CONTACT

904-953-5080; McNew.Stephanie@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 27, 2024
• Study Start: February 20, 2025
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)