Robotic bronchoscopy represents the latest localization technology for peripheral pulmonary nodules, enabling precise and stable manipulation, thereby enhancing the diagnostic yield of peripheral lung pathologies. Its safety and feasibility have been internationally validated, with indications that it can significantly improve the overall diagnostic rate of biopsies for peripheral lung lesions. Nonetheless, the disparity in interventional auxiliary equipment and the level of technical operation is the primary cause for the significant variation in diagnostic rates of peripheral lung lesions across different regions, particularly in remote or underdeveloped areas. The advancement of 5G network technology has propelled the development of telemedicine, enabling remote diagnostics, surgeries, and real-time multi-party collaboration, which is expected to elevate the medical standards in remote areas, improve the diagnostic rate of peripheral lung lesions, and achieve homogenization of medical services. In summary, the integration of 5G with bronchoscopy is anticipated to bring breakthroughs in the diagnosis and treatment of peripheral lung pathologies.
Research Objective:
The primary objective of this clinical trial is to evaluate the safety and efficacy of the remote application of bronchoscopy systems and catheters for the localization and sampling of peripheral pulmonary nodules, under the premise of ensuring the safety of the subjects and the scientific integrity of the clinical trial, with the aid of 5G network.
Research Method:
The study is a prospective, multicenter, single-arm clinical trial with a target value design, intending to include 10 cases of individuals with peripheral pulmonary nodules who are willing to undergo intra-airway examination and sampling operations using remote bronchial navigation localization devices assisted by the 5G communication network. The safety and efficacy of the bronchial navigation localization devices and catheters for the localization and sampling of peripheral pulmonary nodules, developed by Changzhou Langhe Medical Devices Co., Ltd. (hereinafter referred to as "Langhe Medical"), will be assessed.
Analysis:
Statistical data analysis will be performed using SAS software version 9.4 or higher.
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Remote Robotic Bronchoscopy system
Diagnostic testUtilization of a remote robotic bronchoscopy system for the biopsy of patients with pulmonary peripheral lesions
equipment failure rate
The equipment failure rate is calculated as (number of instances of equipment failure / total number of uses) x 100%. Equipment failures are defined as follows: 1. Network delays ≥ 200ms that persist for more than 3 seconds; 2. Any equipment malfunction that results in the cessation of surgery.
Average Latency
Refers to the network data transmission delay, recording the continuous latency data from the start of registration to the end of sampling, and documenting the average, peak, and minimum values.
Bandwidth
Refers to the network transmission rate, recording the network bandwidth from the start of registration to the end of sampling at both control ends, documenting the maximum upload and download bandwidth.
Network Incidents and Recovery Time
Records the specific incidents and quantities of network interruptions and individual stutters \>10 seconds during a single operation.
Sampling yield
Sampling yield = (Total number of cases with non-normal lung tissue obtained by biopsy sampling / Total number of cases undergoing biopsy sampling) × 100%. Note: Definitive sampling includes biopsy pathological results indicating cells/tissues as malignant, benign lesions (such as fungi, tuberculosis, or sarcoidosis, etc.), and non-normal lung tissue that cannot be confirmed.
Diagnostic yield
Diagnostic yield is defined as the proportion of cases diagnosed with bronchoscopy pathology divided by all cases sampled using a specific technology. The bronchoscopy pathology diagnosis only included malignant and specific benign lesions. A lesion was considered malignant if tumor cells were found in histological and/or cytological specimens. Specific benign findings included granuloma, organizing pneumonia, purulence or robust neutrophilic inflammation, and other less common specific benign findings such as those suggesting hamartoma or amyloidoma.
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