A Real-World Case Study Evaluating the Efficacy and Safety of RBS Cryobiopsy (NCT06832930) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Real-World Case Study Evaluating the Efficacy and Safety of RBS Cryobiopsy
200 participantsStarted 2025-02-15
Plain-language summary
The goal of this clinical trial is tois to assess the effectiveness and safety of RBS (Robotic Bronchoscopy System)-assisted cryobiopsy in real-world clinical settings in adult patients (aged ≥18 years) with suspected pulmonary lesions requiring diagnostic bronchoscopic evaluation. The main questions it aims to answer are:
Does RBS-assisted cryobiopsy improve diagnostic yield compared to conventional non-RBS-guided cryobiopsy? Is RBS-assisted cryobiopsy associated with a lower incidence of procedure-related complications (e.g., bleeding, pneumothorax) compared to conventional methods? Researchers will compare the RBS group (patients undergoing RBS-assisted cryobiopsy) with the control group (patients undergoing cryobiopsy with conventional navigation techniques, such as ENB, VBN) to evaluate differences in diagnostic accuracy and safety outcomes.
Participants will:
Provide informed consent for bronchoscopic cryobiopsy. Undergo pre-procedure imaging and clinical evaluation. Receive either RBS-assisted or conventional cryobiopsy based on clinical indication and operator discretion.
Be monitored for immediate and delayed complications .
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years and ≤75 years, with no gender restrictions;
✓. Presence of a peripheral lung lesion on chest CT
✓. Patients voluntarily agree to undergo bronchoscopy and meet the requirements for the procedure;
✓. patients are capable of understanding the purpose of the trial, demonstrate good compliance with the examinations and follow-up, voluntarily participate in the clinical trial, and sign an informed consent form.
Exclusion criteria
✕. Presence of contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe cardiac or pulmonary dysfunction; severe hypertension and arrhythmias; uncorrectable bleeding tendencies or severe coagulation disorders (such as platelet count \<60×10\^9/L), uremia; severe pulmonary artery hypertension; severe superior vena cava syndrome; intracranial hypertension; acute cerebrovascular events; aortic dissection or aneurysm; multiple bullae; extreme systemic exhaustion;
✕. Female patients who are breastfeeding, pregnant, or planning pregnancy;
✕. Patients with electromagnetic active implantable medical devices;
✕. Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history;
✕. Those who have participated in or are currently participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days;
✕. Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.