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

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

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

Study Overview

• Status: Recruiting
• Conditions: Barrett's Esophagus
• Intervention / Treatment: Device: NaviCam Detachable String Capsule

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie McNew; Phone Number: 904-953-5080; Email: McNew.Stephanie@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic in Florida
      • Contact: Stephanie McNew, B.S.; Phone Number: 904-953-0580; Email: mcnew.stephanie@mayo.edu
      • Principal Investigator: Swathi Eluri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Long Segment Barrett's Esophagus (LSBE); Subjects diagnosed with Long Segment Barrett's Esophagus (LSBE)	Device: NaviCam 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.
Experimental: Short Segment Barrett's Esophagus (SSBE); Subjects diagnosed with Short Segment Barrett's Esophagus (SSBE)	Device: NaviCam 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.
Experimental: Gastro Esophageal Reflux Disease; Subjects with Gastro Esophageal Reflux Disease (GERD) who are eligible for Barrett's Esophagus screening	Device: NaviCam 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) is an 11-tem questionnaire assessing pain, where 0 represents the "worst experience" and 10 the "best experience". Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.	30 minutes post-procedure
Spielberger State-Trait Anxiety Inventory (STAI-6)	Patient anxiety will be measured using the shorter 6 item form of the Spielberger State-Trait Anxiety Inventory (STAI-6), with a score over 40 as a threshold for clinically significant anxiety	Baseline, 30 minutes post-procedure
Impact of Events Scale (IES)	The Impact of Events Scale (IES) will be used to assess distress associated with the procedure and procedure acceptability. The IES is rated on a scale of 0 (not at all) to 4 (extremely), with higher scores indicating a greater level of distress.	Baseline, 7 days post-procedure

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Swathi Eluri, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: 24-000150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No