Recruiting

Navicam

Sponsor:

Mayo Clinic

Code:

NCT06748911

Conditions

Barrett's Esophagus

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

NaviCam Detachable String Capsule

Study Details

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

Study ID

NCT06748911

Start date

Feb 20, 2025

Status verified date

Aug, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Enrollment

57 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Long Segment Barrett's Esophagus (LSBE)

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

experimental: Short Segment Barrett's Esophagus (SSBE)

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

experimental: Gastro Esophageal Reflux Disease

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

Interventions

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.

Primary outcome measure

  • Detection of Columnar lined epithelium in the esophagus [ Time Frame: From start of procedure to removal of capsule, assessed up to 30 minutes timeframe from start to end of procedure.. ]

Central Contacts and Locations

Central contacts

Stephanie McNew

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

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Stephanie McNew, B.S.

904-953-0580mcnew.stephanie@mayo.edu

Principal Investigator:

Swathi Eluri

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-19.