Benefit of Cone-beam CT and Robotic-Assisted Bronchoscopy During Bronchoscopy (NCT06489678) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Benefit of Cone-beam CT and Robotic-Assisted Bronchoscopy During Bronchoscopy
Switzerland300 participantsStarted 2024-06-25
Plain-language summary
This randomized controlled trial evaluates the integration of cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) for diagnosing pulmonary lesions, hypothesizing improved diagnostic yield compared to traditional methods. The trial involves 2 study arms (2x46 lesions) over 24 months with 12 months of follow-up and the diagnostic yield (ATS 2024 criteria) as the primary endpoint.
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:
* Aged \>18 years
* Scheduled for bronchoscopy in order to obtain at least 1 specimen(s) of the lung via transbronchial biopsy
* Necessary periinterventional laboratory examinations and other examinations needed for the bronchoscopy
* Informed consent
Exclusion Criteria:
* Not able to tolerate procedure (bronchoscopy or apnea for CBCT)
* Previous randomization to an arm of the present trial
* Endobronchial lesion causing lobar atelectasis
* Inability or contraindications to undergo bronchoscopy (e.g. severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation, psychiatric disorders, or severe neurosis)
* Pregnant or lactating women
For nested RCTs (Trial A + B):
* A: At least 1 peripheral lung lesion suspicious for lung cancer, beyond the visual range of the bronchoscope, rounded or irregular opacity, may be well or poorly defined, measuring ≤3 cm in diameter of the short axis (in CT scan)
* B:At least 1 peripheral target lung lesion of any kind beyond the visual range of the bronchoscope (measuring \>3 cm in diameter of the short axis and/or with an interstitial pattern)
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.
What they're measuring
1
Diagnostic Yield
Timeframe: Including a 12-month follow-up (clinical data)