AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions

NCT ID: NCT06046001

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-27
• Study Completion Date: 2025-01-03

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.

Conditions

Lung Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

AirWaze

AirWaze - easy and advanced tools for CBCT guided lung interventions

Group Type: EXPERIMENTAL

AirWaze

Intervention Type: DEVICE

AirWaze - easy and advanced tools for CBCT guided lung interventions

Interventions

AirWaze

AirWaze - easy and advanced tools for CBCT guided lung interventions

Intervention Type: DEVICE

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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik van der Heijden

Role: PRINCIPAL_INVESTIGATOR

Radboudumc Nijmegen, Netherlands

Locations

Radboudumc

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

XCY607-130895

Identifier Type: -

Identifier Source: org_study_id