WavSTAT study.
- Conditions
- Barrett oesophagusdysplasianeoplasiaadvanced imagingendoscopyBarrett slokdarmdysplasieslokdarmkankergeavanceerde detectieendoscopie
- Registration Number
- NL-OMON23646
- Lead Sponsor
- AMC Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 170
Inclusion Criteria
1. Age > 18 – 80 years;
2. BO with a minimal circumferential length of 2 cm;
Exclusion Criteria
1. Prior history of surgical or endoscopic treatment for oesophageal neoplasia;
2. Presence of erosive oesophagitis (Los Angeles classification ≥B);
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1 will be used to develop a tissue recognition algorithm by correlating 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 following outcome parameters:<br /><br>1. Sensitivity and specificity of WavSTAT for the detection of early Barrett neoplasia (HGIN/EC);<br /><br>2. Additional value of WavSTAT to standard inspection with WLE, compared to inspection with WLE alone for the detection of early Barrett neoplasia (HGIN/EC).
- Secondary Outcome Measures
Name Time Method