AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions

Lung Diseases Clinical Trial

Official title:

AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06046001
• Other study ID #: XCY607-130895
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2023
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Philips Clinical & Medical Affairs Global
• Contact: Pim van Lochem
• Phone: +31 6 18 19 87 71
• Email: pim.vanlochem[@]philips.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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.

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Device:
• AirWaze
AirWaze - easy and advanced tools for CBCT guided lung interventions

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System Usability Score (SUS)	System Usability Score (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.	Pre-procedure and immediately after the procedure
Primary	Accuracy of the tool-in-lesion confirmation scan assessed by questionnaire "CBCT-FS compared to CBCT".	Accuracy of the tool-in-lesion confirmation scan compared to the conventional scan based on questionnaire about tool-in-lesion definitions and usefulness of the scans to guide to the lesion (questionnaire "CBCT-FS compared to CBCT"). Image based tool-in-lesion confirmation accuracy of 90% will indicate that the CBCT-FS is postulated to be sufficient for navigation bronchoscopy.	Immediately after the procedure