Navicam for Detection of Barrett's Esophagus

Not Applicable

Recruiting

• Conditions: Barrett's Esophagus

• Registration Number: NCT06748911
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-27
• Study Start: 2025-02-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-02
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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..	Detection of Columnar lined epithelium in the esophagus

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	30 minutes post-procedure	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.
Spielberger State-Trait Anxiety Inventory (STAI-6)	Baseline, 30 minutes post-procedure	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
Impact of Events Scale (IES)	Baseline, 7 days post-procedure	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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States