Comparative Performance of Robotic, Electromagnetic Navigation and Fluoroscopy Drives Optimal Dia… (NCT06701448) | Clinical Trial Compass
CompletedNot Applicable
Comparative Performance of Robotic, Electromagnetic Navigation and Fluoroscopy Drives Optimal Diagnostic Strategy for Peripheral Pulmonary Lesions
China342 participantsStarted 2019-04-01
Plain-language summary
Currently, the optimal method for Peripheral Pulmonary Lesions (PPL) is uncertain. We aim to compare the diagnostic yield of Robotic Bronchoscopy System (RBS), Electromagnetic Navigation Bronchoscopy (ENB), Fluoroscope-Bronchoscopy (FB).
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;