Self-driving robotic-assisted bronchoscope: All procedures will be performed under general anesthesia with endotracheal intubation and mechanical ventilation. The self-driving robotic-assisted bronchoscope will automatically advance through airway to the target lesion according to the preoperative planning path under the guidance of electromagnetic navigation. After that, the bronchoscopist will use radial endobronchial ultrasound (rEBUS) to confirm the lesion localization. The choice of biopsy tools (eg. forceps, needles, brush, etc.) will be left to the discretion of the bronchoscopist.
Study summary
This is a single-center, prospective, and single-arm study. The purpose of this study is to evaluate the feasibility and safety of a new self-driving robotic-assisted bronchoscopic system for the diagnosis of peripheral pulmonary nodules.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients older than 18 years old.
2. Presence of a peripheral pulmonary nodule (8 mm \< diameter ≤ 30 mm) on thin-section chest CT that is suspected to be malignant and requires non-surgical biopsy.
3. Patients have good medical adherence and signed informed consent.
Exclusion Criteria:
1. Presence of contraindications to bronchoscopy under general anesthesia.
2. Presence of concomitant endobronchial lesion during the bronchoscopy procedure.
3. The investigators believe that patient has other conditions that are not suitable for the study.
Primary outcome measure(s)
Navigation success rate — 1 month Navigation success is defined as: (1) confirmation of the target lesion under rEBUS and/or fluoroscopy that allows lesion sampling, (2) positioning of the bronchoscope tip within ≤3 cm of the virtual lesion that allows lesion sampling, or (3) acquisition of a malignant or specific benign diagnosis via the procedure.
Trial sites (1)
Facility
City
Region
Status
Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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