Abstract
Background:
Cone-beam computed tomography (CBCT)- guided bronchoscopy is an established technique for diagnosing peripheral pulmonary lesions, offering 3-dimensional imaging for both navigation and confirmation. However, its usability as a stand-alone modality is limited by a substantial learning curve and a lack of integrated planning tools. This study evaluates the feasibility and performance of navigation bronchoscopy-specific CBCT software that enables preprocedural CT-planning fusion with intraprocedural CBCT imaging and provides intraprocedural support algorithms.
Methods:
This prospective, single-center clinical feasibility study exploratively assessed the usability of the AirWaze investigational software. Usability was measured using a standardized system usability score, with scores of 70 or higher considered indicative of good usability (range, 0-100). The performance of the individual software components (‘planning,’ ‘image fusion,’ and ‘guidance’) was evaluated. An ultralow-dose CBCT protocol was compared with conventional CBCT scans for accuracy and radiation exposure.
Results:
The study enrolled 34 patients with 37 lesions. The investigational software achieved a system usability score of 45. The planning component was available in all cases and was unanimously rated by the endoscopists as accurate and intuitive. In contrast, the image fusion and guidance components were rated as insufficient. The ultralow-dose CBCT protocol provided clinically accurate imaging in 84% of cases and reduced the radiation dose by 94%.
Conclusion:
Integrating planning and procedural guidance within stand-alone CBCT-guided navigation bronchoscopy procedures has great potential. Although several components of the investigational software were considered valuable, further development is required to ensure comprehensive procedural guidance.