Diagnose longlesies Lung diagnosis
Conditions
Interventions
Current clinical practice
• Pre-procedural
In current clinical practice, the lesion identification and trajectory planning
are performed by interventional pulmonologists who need to mentally reconstr
Sponsors
Philips
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age 18 years or older at the time of informed consent. • ASA physical status between 1 and 3. • Subject is willing and able to give written informed consent for clinical investigation participation prior to the procedure. • Subject has a pulmonary lesion with an indication for diagnostic evaluation following current clinical guidelines and/or as decided by multi-disciplinary team consultation. • Suitable for CBCT-guided endobronchial nodule biopsy under general anaesthesia. • Pre-procedural (PET-)CT scan is available prior to the CBCT-NB intervention.
Exclusion criteria
Exclusion criteria: • Aged 17 or younger at the time of informed consent. • ASA physical status is equal to and greater than 4. • Not willing or not able to give informed consent. • Does not indicate diagnostic evaluation with navigation bronchoscopy. • Not suitable for CBCT-guided endobronchial nodule biopsy via navigation bronchoscopy under general anaesthesia. • There is no recent pre-procedural (PET-)CT scan available. • Known bleeding disorders. • Contra-indication for temporary interruption of the use of anticoagulant therapy, such as acenocoumarol, warfarin, therapeutic dose of low molecular weight heparins, clopidogrel, or analogues, NOACs). • Known allergy for lidocaine or other allergies interfering with the procedure. • Uncontrolled pulmonary hypertension. • Recent and/or uncontrolled cardiac disease. • Compromised upper airway (e.g. concomitant head and neck cancer or central airway stenosis for any reason such that endobronchial access is considered unsafe). • Potentially confounding drug or device trial during the course of the clinical study. Co-enrollment in concurrent trials may be allowed provided pre-approval is obtained from the Philips Clinical Study Manager. • All vulnerable subjects, such as immune-compromised subjects, subjects lacking the capacity to provide consent, patients in emergencies, pregnant or breastfeeding women, or any other subject who meets exclusion criteria, according to applicable national laws, if any. • Woman of childbearing potential who is known to be pregnant on admission. • Any condition that in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the subject in the study. • Subject is Philips employee or their family members residing with this Philips employee.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint - System Usability Score (SUS) of AirWaze investigational device. - Accuracy of the tool-in-lesion confirmation scan CBCT-FS compared to the conventional CBCT (gold-standard) based on tool-in-lesion definitions and usefulness of the scans in order to guide to the lesion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints The secondary endpoints of this clinical feasibility investigation are: - Semi-structured questionnaires to assess intuitiveness of AirWaze features for CBCT-guided biopsy of peripheral pulmonary nodules. - Quantitative and qualitative assessment of developed algorithms: a) Segmentation bronchial tree on pre-procedural CT. b) Elastic registration of the intraoperative CBCT scans with preprocedural CT scan. c) Automatic device detection on intraoperative CBCT scans. - The quality of the interventional planning utilizing the AirWaze planning software assessed by semi-structured questionnaires. - Confidence levels of pulmonologists regarding: (i) the localization of the lesion and planned navigation trajectory; (ii) reaching the first pulmonary lesion based on the planning assessed by semi-structured questionnaires. - The cognitive load of pulmonologists during CBCT-guided navigation to the first pulmonary lesion assessed by semi-structured questionnaires. - Radiation exposure for patients and staff. - Adverse events, adverse device effects and device deficiencies. | — |
Countries
Netherlands
Outcome results
None listed