Navicam for Detection of Barrett's Esophagus

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT06748911
Status
Recruiting
Apply to this trial

Conditions

  • Barrett's Esophagus

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Feb 20, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
57 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224
Stephanie McNew, B.S.
[email protected]
904-953-0580
Swathi Eluri (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Florida· Jacksonville, FL

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