Navicam for Detection of Barrett's Esophagus

NCT ID: NCT06748911

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-20

Study Completion Date

2026-05-31

Brief Summary

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

Detailed Description

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Conditions

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Barrett's Esophagus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Long Segment Barrett's Esophagus (LSBE)

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

Group Type EXPERIMENTAL

NaviCam Detachable String Capsule

Intervention Type 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.

Short Segment Barrett's Esophagus (SSBE)

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

Group Type EXPERIMENTAL

NaviCam Detachable String Capsule

Intervention Type 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

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

Group Type EXPERIMENTAL

NaviCam Detachable String Capsule

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Swathi Eluri

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Swathi Eluri

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stephanie McNew

Role: CONTACT

904-953-5080

Facility Contacts

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Stephanie McNew, B.S.

Role: primary

904-953-0580

Other Identifiers

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24-000150

Identifier Type: -

Identifier Source: org_study_id

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