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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.
Self-driving robotic-assisted bronchoscope (Shanghai MicroPort MedBot (Group) Corporation Limited, China) is a new robotic-assisted bronchoscopic system that can automatically advance through airway according to the preoperative planning path under the guidance of electromagnetic navigation. It can also be controlled manually by the operator. In this study, 30 patients will be prospectively enrolled to evaluate the feasibility and safety of this new self-driving robotic-assisted bronchoscopic system for the diagnosis of peripheral pulmonary nodules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with peripheral pulmonary nodules | Experimental | 30 patients with peripheral pulmonary nodules who meet the inclusion and exclusion criteria will be prospectively enrolled. Self-driving robotic-assisted bronchoscopy will be performed to diagnose the lesions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-driving robotic-assisted bronchoscope | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Navigation success rate | 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield | A procedure is deemed diagnostic if a specific benign or malignant diagnosis is made. | 1 month |
| Rate of rEBUS confirmation | rEBUS confirmation is defined as visualization of target lesion using rEBUS during the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayuan Sun, MD, PhD | Contact | 86-021-22200000 | 1511 | jysun1976@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiayuan Sun | Shanghai Chest Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | China |
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| During the procedure |
| Total examination time | Total examination time is defined from the time that the bronchoscope is inserted beyond the glottis, until the bronchoscope has been removed from the glottis after examination. | During the procedure |
| Navigation time | Navigation time is defined as the time from the start of the self-driving robotic-assisted bronchoscope advancing under the guidance of electromagnetic navigation to the insertion of the ultrasound probe. | During the procedure |
| Duration of finding lesions | Duration of finding lesions is defined from the insertion of the ultrasound probe to the withdrawal of the ultrasound probe. | During the procedure |
| Complication rate | The complications refer to the total of device or procedure related adverse events during or within 1 month after the operation. | 1 month |