New device aims to make lung biopsies safer and more precise
NCT ID NCT06046001
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tested a new navigation device called AirWaze, designed to help doctors perform lung biopsies using CT scans. 37 adults with lung lesions underwent a bronchoscopy procedure with the device. The main goals were to see if the device was easy to use and if it could accurately confirm that the biopsy tool reached the right spot, potentially using a lower-dose CT scan.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AirWaze device (navigation software for bronchoscopy)
- What this could lead to
- If successful, this device could make lung biopsies more accurate and reduce radiation exposure during the procedure.
- What could go wrong
- This is a small, completed usability study with only 37 participants. It does not test whether the device improves patient outcomes, only that it is easy to use and accurate for confirming tool placement.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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37 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Jan 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
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