High Resolution Optical Imaging of Barrett*s Esophagus Using N-Vision pVLE

Withdrawn

• Conditions: 1) Barrett's oesophagus; 10017990; 2) early oesophageal cancer; 10017991

• Registration Number: NL-OMON37408
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

- age over 18 years
- patients referred with Barrett's oesophagus with and without early neoplasia
- written informed consent

Exclusion Criteria

- patients with a condition precluding full distension of the N-Vision balloon, such as strictures or a mass
- inability to obtain biopsies (e.g. due to antocoagulation therapie, coagulation disorder, varices)
- eosophillic oesophagitis
- pregnancy
- unable to provide signed informed consent.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Phase 1<br /><br><br /><br>1) feasibility of the system<br /><br>2) the capacity of the system to construct a high-resolution map of the mucosal<br /><br>lining of the oesophagus<br /><br>3) the capacity of detecting areas suspicious for neoplasia (by correlating the<br /><br>suspicious areas identified by the N-Vision system to the histological<br /><br>diagnosis of the biopsy specimen of that particular area).<br /><br><br /><br>Phase 2<br /><br><br /><br>1) sensitivity and specificity of the pVLE system for the detection of early<br /><br>neoplasia in BE<br /><br>2) additional value of the pVLE system over the assessment of the endoscopist<br /><br>alone.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>--</p><br>