Feasibility and Safety of Remote Robotic Bronchoscopy System in Diagnosis of Peripheral Pulmonary Lesions: a Multicenter, Randomized Controlled, Proof-of Concept Trial

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.

NCT Number	NCT06613412
Lead Sponsor	Guangzhou Medical University
Conditions	Pulmonary Nodule
Enrollment	10 participants
Start Date	2024-09-15
Primary Completion	2024-12-31 (estimated)
Study Completion	2025-02-15 (estimated)
Updated on ClinicalTrials.gov	2024-11-22