Peripheral Pulmonary Nodules
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICESelf-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.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | 1 month | A procedure is deemed diagnostic if a specific benign or malignant diagnosis is made. |
| Rate of rEBUS confirmation | During the procedure | rEBUS confirmation is defined as visualization of target lesion using rEBUS during the procedure. |
| Total examination time | During the procedure | 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. |
| Navigation time | During the procedure | 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. |
| Duration of finding lesions | During the procedure | Duration of finding lesions is defined from the insertion of the ultrasound probe to the withdrawal of the ultrasound probe. |
| Complication rate | 1 month | The complications refer to the total of device or procedure related adverse events during or within 1 month after the operation. |
Countries
China
Contacts
CONTACTJiayuan Sun, MD, PhD
STUDY_DIRECTORJiayuan Sun
Shanghai Chest Hospital
Outcome results
None listed