Lung Diseases
Conditions
Brief summary
The goal of this clinical trial is to assess the overall usability of the Philips AirWaze investigational device in patients indicated for CBCT-guided navigation bronchoscopy procedure. The main questions it aims to answer are to assess the: * overall usability of the device * accuracy of the tool-in-lesion confirmation scan Participants will undergo bronchoscopy with the new navigation device and additional confirmation scans. Follow-up visit at 7days will be performed.
Interventions
DEVICEAirWaze
AirWaze - easy and advanced tools for CBCT guided lung interventions
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) | after procedure, up to 2 hours | System Usability Scale (SUS) of AirWaze investigational device. An average SUS of greater than 70 will indicate a good usability design of the AirWaze Software solution. The SUS will be measured per operator every 4 procedures. The questionnaire consists of a 10-item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Minimum total score is 0 and maximum, 100. |
| Number of Participants With Accurate Tool-in-lesion Confirmation Scan (Ultra-low Dose CBCT Scan) Compared to the Conventional Tool-in-lesion Confirmation Scan (CBCT Scan) | after procedure, up to 1 hour | Accuracy of the tool-in-lesion confirmation scan (ultra-low dose CBCT scan) is defined as the number of participants where ultra-low dose CBCT scans were adequate to define tool-in-lesion compared to conventional CBCT scans (gold-standard). The accuracy is defined as the sum of the number of tool-in-lesion scans in both the ultra-low dose CBCT and conventional CBCT scans (i.e. true positives), and the number of no tool-in-lesion confirmation in both the ultra-low dose CBCT and conventional CBCT scans (i.e. true negatives), divided by the total number of ultra-low dose CBCT and conventional CBCT scan pairs. Image based tool-in-lesion confirmation accuracy of 90% will indicate that the ultra-low dose CBCT scan is postulated to be sufficient for navigation bronchoscopy. |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORErik van der Heijden
Radboudumc Nijmegen, Netherlands
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 10.9 |
| BMI | 25.7 kilograms per square meters STANDARD_DEVIATION 4.19 |
| Height | 173.4 cm STANDARD_DEVIATION 8.55 |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 19 Participants |
| Weight | 77.5 kg STANDARD_DEVIATION 14.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 37 |
| other Total, other adverse events | 4 / 37 |
| serious Total, serious adverse events | 2 / 37 |
Outcome results
None listed