Evaluation of the WavSTAT Optical Biopsy System for the detection of early neoplasia in the Barrett oesophagus

Completed

Conditions: 1) Barrett oesophagus
2) early oesophageal cancer
10017990
10017991

Registration Number: NL-OMON35892

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 129

Inclusion Criteria

- Age > 18 * 80 years;
- BO with a minimal circumferential length of 2 cm;
- BO without dysplasia (NDBO) and patients with BO referred for endoscopic work-up of HGIN or EC;
- Signed informed consent.

Exclusion Criteria

- Prior history of surgical or endoscopic treatment for oesophageal neoplasia;
- Presence of erosive oesophagitis (Los Angeles classification *B);
- Inability to obtain biopsies (e.g. due to anticoagulation, coagulation disorders, varices);
- 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 will be used to develop a tissue recognition algorithm by correlating<br /><br>the measured fluorescence spectra to the histology of the corresponding tissue.<br /><br><br /><br>In phase 2 the WavSTAT optical biopsy will be validated and assessed for the<br /><br>following outcome parameters:<br /><br>1. sensitivity and specificity of WavSTAT for the detection of early Barrett<br /><br>neoplasia (HGIN/EC)<br /><br>2. additional value of WavSTAT to standard inspection with WLE, compared to<br /><br>inspection with WLE alone for the detection of early Barrett neoplasia<br /><br>(HGIN/EC).</p><br>

Secondary Outcome Measures