Virtual Bronchoscopic Navigation to Increase Diagnostic Yield in Patients With Pulmonary Nodules (NCT05383105) | Clinical Trial Compass
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Virtual Bronchoscopic Navigation to Increase Diagnostic Yield in Patients With Pulmonary Nodules
Netherlands100 participantsStarted 2021-02-01
Plain-language summary
Background Transthoracic computed tomography (CT)-guided procedures are the current gold Standard for obtaining diagnostic biopsies of solitary pulmonary nodules (SPN) in the peripheral lung. Novel endobronchial techniques, such as electromagnetic navigation bronchoscopy (ENB) or Virtual bronchoscopic navigation (VBN) are considered safer to approach SPNs.
The newest technique combines VBN with calculating the access to a SPN via a transparenchymal route. In contrast to the gold Standard transthoracic approach, also small lesions, and lesions which cannot be reached transthoracicaliy, located in the innertwo thirdsof the lung can be approached.
Main research question To assess diagnostic yield of the novel Standard of care 'Virtual bronchoscopy navigation" procedure.
Design (including population, confounders/outcomes) A single centre, prospective, observational study of patients undergoing the novel Standard of care Virtual bronchoscopy navigation procedure to assess a pulmonary nodule. Clinical data of at least 100 consecutive patients will be collected.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age \>18
* pulmonary nodule(s) suspicious for malignancy or metastases of a known primary tumour
* a distinct nodule with a diameter of \>6 mm in its largest dimension
* nodule located in the parenchymal tissue \>1 cm from the pleura and bronchoscopically accessible through a point of entry
* willing to give informed consent to the procedure.
Exclusion Criteria:
* any contraindication to undergo bronchoscopy
* contraindication for general anaesthesia
* inability to stop anticoagulants or antiplatelets agents according to the UMCG protocol
* childbearing or breastfeeding women
* moderate to seyere pulmonary fibrosis
* severe emphysema with bullae \> 5 cm m the vicinity of the target nodule or tunnel.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.