Clinical trial NCT06046001: AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions
Official title: AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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:

* 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.

Primary outcomes:
measure: System Usability Score (SUS)
timeFrame: Pre-procedure and immediately after the procedure
measure: Accuracy of the tool-in-lesion confirmation scan assessed by questionnaire "CBCT-FS compared to CBCT".
timeFrame: Immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboudumc Nijmegen, Netherlands
name: Erik van der Heijden
role: PRINCIPAL_INVESTIGATOR
References: