Lung Cancer, Clinical Trial
Official title:
Development and Evaluation of Clinical Utility of Virtual Bronchoscopy (VB)-Based System for Bronchoscopic Navigation, Mediastinal Mapping and Transbronchial Aspiration of Mediastinal Lesions.
The study has been designed to evaluate the clinical application of the new virtual
bronchoscopy (VB) -based system for transbronchial sampling of the mediastinal masses or
enlarged lymph nodes. The software uses data from thorax CT scan and enables airway
segmentation and reconstruction simultaneously with predefined mediastinal targets. The most
suitable sites for transbronchial needle aspiration are displayed on the internal surface of
the airways showed in VB mode.
The diagnostic yield of the new system-assisted TBNA will be compared to the reference
method (EBUS-TBNA). The study group includes patients with mediastinal mass or lymph node
enlargement in whom diagnostic bronchoscopy and TBNA can be applied as diagnostic methods.
Both, virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA) and EBUS-TBNA
of the mediastinal targets are performed during the same diagnostic bronchoscopy. Cytologic
material from VB-TBNA and EBUS-TBNA is evaluated by two independent pathologists blinded to
the method used to obtain the sample. Diagnostic yield and adequacy of aspirates obtained
with the two methods will be assessed and compared.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01211015 -
Endoplasmic Reticulum Stress in Chronic Respiratory Diseases
|
N/A |