WavSTAT study.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23646

Enrollment

170

Registered

2011-04-18

Start date

2011-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett oesophagus dysplasia neoplasia advanced imaging endoscopy Barrett slokdarm dysplasie slokdarmkanker geavanceerde detectie endoscopie

Interventions

Phase 1: Development of algorithm for the WavSTAT system in 20 patients

Phase 2: Validation of the WavSTAT system in 150 patients.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 – 80 years; 2. BO with a minimal circumferential length of 2 cm; 3. BO without dysplasia (NDBO) and patients with BO referred for endoscopic work-up of HGIN or EC; 4. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Prior history of surgical or endoscopic treatment for oesophageal neoplasia; 2. Presence of erosive oesophagitis (Los Angeles classification ≥B); 3. Inability to obtain biopsies (e.g. due to anticoagulation, coagulation disorders, varices); 4. Unable to provide signed informed consent.

Design outcomes

Primary

Measure	Time frame
Phase 1 will be used to develop a tissue recognition algorithm by correlating the measured fluorescence spectra to the histology of the corresponding tissue. In phase 2 the WavSTAT optical biopsy will be validated and assessed for the following outcome parameters: 1. Sensitivity and specificity of WavSTAT for the detection of early Barrett neoplasia (HGIN/EC); 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).	—

Measure

Time frame

Phase 1 will be used to develop a tissue recognition algorithm by correlating the measured fluorescence spectra to the histology of the corresponding tissue. In phase 2 the WavSTAT optical biopsy will be validated and assessed for the following outcome parameters: 1. Sensitivity and specificity of WavSTAT for the detection of early Barrett neoplasia (HGIN/EC); 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).

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Contacts

Public ContactDavid Boerwinkel

Meibergdreef 9

d.f.boerwinkel@amc.uva.nl+31 (0)20 5664571

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)