Trial Outcomes & Findings for AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions (NCT NCT06046001)
NCT ID: NCT06046001
Last Updated: 2026-04-16
Results Overview
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.
COMPLETED
NA
37 participants
after procedure, up to 2 hours
2026-04-16
Participant Flow
Participant milestones
| Measure |
AirWaze (Enrolled Population)
The Enrolled Population was defined as all subjects who signed informed consent during the study and planned for CBCT-guided navigation bronchoscopy supported by the AirWaze investigational device.
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|---|---|
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Overall Study
STARTED
|
37
|
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Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
AirWaze (Enrolled Population)
The Enrolled Population was defined as all subjects who signed informed consent during the study and planned for CBCT-guided navigation bronchoscopy supported by the AirWaze investigational device.
|
|---|---|
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Overall Study
Protocol Violation
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
System defect (not investigational device)
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AirWaze (Per Protocol Population)
n=34 Participants
The Per Protocol Population was defined as all subjects in the Enrolled Population which underwent CBCT-guided navigation bronchoscopy supported by the AirWaze investigational device without major protocol deviations.
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|---|---|
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Age, Continuous
|
64.9 years
STANDARD_DEVIATION 10.90 • n=34 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=34 Participants
|
|
Height
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173.4 cm
STANDARD_DEVIATION 8.55 • n=34 Participants
|
|
Weight
|
77.5 kg
STANDARD_DEVIATION 14.30 • n=34 Participants
|
|
BMI
|
25.7 kilograms per square meters
STANDARD_DEVIATION 4.19 • n=34 Participants
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PRIMARY outcome
Timeframe: after procedure, up to 2 hoursSystem 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.
Outcome measures
| Measure |
AirWaze (Per Protocol Population)
n=34 Participants
The Per Protocol Population was defined as all subjects in the Enrolled Population which underwent CBCT-guided navigation bronchoscopy supported by the AirWaze investigational device without major protocol deviations.
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|---|---|
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System Usability Scale (SUS)
|
44.7 units on a scale
Standard Deviation 24.35
|
PRIMARY outcome
Timeframe: after procedure, up to 1 hourPopulation: All participants with an ultra-low dose CBCT scan and a conventional CBCT scan to confirm tool-in-lesion with the same catheter and tool position, are included in this analysis. For 9 of the 34 participants, no ultra-low dose CBCT scan and/ or conventional CBCT scan was performed to confirm tool-in-lesion and therefore no tool-in-lesion accuracy was determined.
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.
Outcome measures
| Measure |
AirWaze (Per Protocol Population)
n=25 Participants
The Per Protocol Population was defined as all subjects in the Enrolled Population which underwent CBCT-guided navigation bronchoscopy supported by the AirWaze investigational device without major protocol deviations.
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|---|---|
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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)
|
21 Participants
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Adverse Events
AirWaze (Enrolled Population)
Serious adverse events
| Measure |
AirWaze (Enrolled Population)
n=37 participants at risk
The Enrolled Population was defined as all subjects who signed informed consent during the study and planned for CBCT-guided navigation bronchoscopy supported by the AirWaze investigational device.
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|---|---|
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Cardiac disorders
Chest pain
|
2.7%
1/37 • from enrollment until end of follow-up, up to 1 week
The following adverse events do not need to be reported if occurred within the 48h timeframe: * Haemoptysis (May occur after bronchoscopy by causing damage to the airway walls or taking biopsies in the lung parenchyma. These inconveniences will disappear within 48 hours), * Fever (May occur after the procedure. Is no reason for alarm and can be treated with antipyretic medication, such as paracetamol)
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|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.7%
1/37 • from enrollment until end of follow-up, up to 1 week
The following adverse events do not need to be reported if occurred within the 48h timeframe: * Haemoptysis (May occur after bronchoscopy by causing damage to the airway walls or taking biopsies in the lung parenchyma. These inconveniences will disappear within 48 hours), * Fever (May occur after the procedure. Is no reason for alarm and can be treated with antipyretic medication, such as paracetamol)
|
Other adverse events
| Measure |
AirWaze (Enrolled Population)
n=37 participants at risk
The Enrolled Population was defined as all subjects who signed informed consent during the study and planned for CBCT-guided navigation bronchoscopy supported by the AirWaze investigational device.
|
|---|---|
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Nervous system disorders
Back pain
|
2.7%
1/37 • from enrollment until end of follow-up, up to 1 week
The following adverse events do not need to be reported if occurred within the 48h timeframe: * Haemoptysis (May occur after bronchoscopy by causing damage to the airway walls or taking biopsies in the lung parenchyma. These inconveniences will disappear within 48 hours), * Fever (May occur after the procedure. Is no reason for alarm and can be treated with antipyretic medication, such as paracetamol)
|
|
Injury, poisoning and procedural complications
Bleeding
|
2.7%
1/37 • from enrollment until end of follow-up, up to 1 week
The following adverse events do not need to be reported if occurred within the 48h timeframe: * Haemoptysis (May occur after bronchoscopy by causing damage to the airway walls or taking biopsies in the lung parenchyma. These inconveniences will disappear within 48 hours), * Fever (May occur after the procedure. Is no reason for alarm and can be treated with antipyretic medication, such as paracetamol)
|
|
Infections and infestations
Fever
|
2.7%
1/37 • from enrollment until end of follow-up, up to 1 week
The following adverse events do not need to be reported if occurred within the 48h timeframe: * Haemoptysis (May occur after bronchoscopy by causing damage to the airway walls or taking biopsies in the lung parenchyma. These inconveniences will disappear within 48 hours), * Fever (May occur after the procedure. Is no reason for alarm and can be treated with antipyretic medication, such as paracetamol)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.7%
1/37 • from enrollment until end of follow-up, up to 1 week
The following adverse events do not need to be reported if occurred within the 48h timeframe: * Haemoptysis (May occur after bronchoscopy by causing damage to the airway walls or taking biopsies in the lung parenchyma. These inconveniences will disappear within 48 hours), * Fever (May occur after the procedure. Is no reason for alarm and can be treated with antipyretic medication, such as paracetamol)
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Additional Information
Pim van Lochem
Philips Medical Systems Nederland B.V.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place