Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions (NCT05526573) | Clinical Trial Compass
UnknownNot Applicable
Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions
Italy148 participantsStarted 2022-07-14
Plain-language summary
The use of an ultrathin bronchoscope (UB) has recently been introduced in the diagnosis of peripheral lung lesions. The use of the UB can be supported by navigation systems such as fluoroscopy, ultrasound guidance, electromagnetic navigation, or other technologies, which have complementary potential. Further navigation techniques are still under study. The use of ultrathin instrumentation has already been shown to significantly reduce procedural times compared to traditional instrumentation.
The purpose of the study is to prospectively evaluate the institutional experience of different third-level hospital centers with the use of a UB (MP190F; Olympus Medical Systems, Tokyo, Japan) for sampling peripheral lung lesions by means of transbronchial needle aspiration (TBNA) or transbronchial biopsy (TBB), performed after fluoroscopic navigation and simultaneous radial probe-endobronchial ultrasound (RP-EBUS) assessment.
Design: multicentric, observational study.
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:
* Candidate for a diagnostic procedure for a new peripheral lung lesion or re-biopsy;
* Tissue sampling of the peripheral lesion performed only with UB;
* The patient's ability to understand the individual characteristics and consequences of the clinical study;
* Males and females of any ethnicity;
* Subjects who have given their informed consent to use their clinical data for research purposes.
Exclusion criteria:
* Inability to give informed consent or understand its contents;
* Unavailability of tomographic imaging;
* Failure to use RP-EBUS or fluoroscopic guidance during the procedure;
* Failure to use R.O.S.E. by the pulmonologist or pathologist during the procedure;
* Tissue sampling on the same peripheral lesion using an instrument of a different caliber in replacement or in association;
* Any other significant illness or disorder that, in the investigator's opinion, may put the patient at risk due to study participation.
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
Evaluate the overall diagnostic accuracy
Timeframe: Within 12 months from the procedure
Trial details
NCT IDNCT05526573
SponsorAzienda Sanitaria-Universitaria Integrata di Udine