Key Takeaways & Executive Findings
- •• The robotic navigation system significantly improved puncture accuracy: one-time success rate of 98.31% versus 15.00% in the control group. • Complication rates were lower with the robotic system (6.78%) compared to conventional CT-guided puncture (13.33%). • The system achieved 100% usability satisfaction, indicating high clinical acceptance. • The robotic system integrates optical navigation, surgical planning, and robotic arm puncture to enable real-time monitoring and precise targeting.
Abstract
BACKGROUND: Conventional percutaneous CT-guided interventional puncture cannot be monitored in real time, and the operation takes a long time. In some high-risk puncture sites, multiple CT scans and adjustments to the position of the puncture needle are required, causing greater radiation damage to the patient. A self-developed surgical navigation and positioning system provides an effective way to solve the clinical problems of percutaneous puncture information perception and accurate and safe target puncture in complex intraoperative environments, achieving precise puncture positioning of the chest and abdomen. OBJECTIVE: To evaluate the safety, effectiveness and usability of the self-developed percutaneous puncture navigation robotic system in clinical application. METHODS: A retrospective analysis was conducted on clinical trial data from percutaneous lung nodule biopsy and tumor ablation procedures guided by a puncture navigation robotic system at the First Affiliated Hospital of Guangzhou Medical University and the Second Affiliated Hospital of Soochow University between November 1, 2021 and June 28, 2022. A multicenter, open-label, parallel controlled clinical study was conducted, and 120 subjects were randomly divided into an experimental and a control group, with 60 subjects in each group. The experimental group underwent puncture guided by a puncture navigation robotic system, while the control group underwent conventional CT-guided percutaneous puncture. The primary effectiveness endpoint was puncture accuracy rate, and secondary endpoints included number of needle adjustments, one-time success rate of puncture, number of CT scans, and system usability. RESULTS AND CONCLUSION: No unsafe events occurred during the entire clinical trial. The one-time success rate of puncture was 98.31% in the experimental group and 15.00% in the control group; complication rates were 6.78% and 13.33%, respectively. The system usability satisfaction rate was 100%. The system achieved interactive modeling of puncture needle and soft tissue, dynamic reconstruction of complex operative environment and real-time perception of puncture information, and dynamic navigation and tracking compensation under physiological motion and puncture interaction, providing an effective solution to the clinical challenges of information perception and accurate and safe target puncture in complex intraoperative environments.
1. Introduction
Conventional percutaneous CT-guided interventional puncture cannot be monitored in real time, and the operation is time-consuming. In some high-risk puncture areas, multiple CT scans and needle adjustments are required, causing significant radiation exposure to patients. According to literature, image-guided puncture under X-ray, CT, or ultrasound can effectively reach lesions, but limitations such as low resolution and artifacts lead to variable biopsy accuracy (61%-90%) and complication rates (0-10%). CT-guided puncture has significantly reduced success for nodules smaller than 8 mm, and nodules adjacent to the heart, great vessels, or mediastinum may be inaccessible due to safety concerns. Poor respiratory cooperation (e.g., in COPD patients) increases procedural difficulty.
Compared with conventional CT-guided puncture, robotic systems can shorten operation time, reduce trauma, improve accuracy, and decrease radiation exposure, thereby shortening patient recovery. Robotic-guided percutaneous intervention offers advantages of minimal invasiveness, strong targeting, repeatability, and patient acceptance, and is widely used in tissue biopsy and tumor ablation. Recent technological advances have led to the development of interventional robotic systems, 3D-printed navigation templates, and augmented reality (AR) navigation. However, currently approved puncture robots in China have limitations; none possess the full capabilities of image analysis and path planning, robotic arm puncture, and real-time environmental sensing. The self-developed surgical navigation and positioning system used in this study comprises an optical navigation system, a surgical planning system, and a robotic arm-guided puncture system, enabling precise robotic-assisted puncture of nodules and improving targeting accuracy.
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CHEN Xiangqian, ZHANG Haoren, GUO Jian, HE Jianhang, SHI Yue (2026). Clinical trial of a robotic system for puncture navigation and positioning. Chinese Journal of Tissue Engineering Research. https://doi.org/10.12307/2026.21377
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Frequently Asked Questions
What is the main advantage of the robotic puncture navigation system over conventional CT-guided puncture?
The robotic system significantly improves puncture accuracy (one-time success rate 98.31% vs 15.00%) and reduces complication rates (6.78% vs 13.33%), while also minimizing radiation exposure and procedure time.
How does the robotic system achieve real-time monitoring during puncture?
The system integrates an optical navigation system (the 'eye'), a surgical planning system (the 'brain'), and a robotic arm puncture system (the 'hand'), enabling dynamic reconstruction of the operative environment and real-time perception of puncture information.
What were the inclusion criteria for the clinical trial?
The trial included patients requiring lung nodule biopsy or tumor ablation of chest or abdominal lesions, and was conducted at two centers between November 2021 and June 2022.
What is the clinical significance of the 100% usability satisfaction?
The 100% usability satisfaction indicates that the system is user-friendly and easily adopted by clinicians, which is crucial for its integration into routine clinical practice.
What are the potential applications of this robotic system?
The system is designed for precise percutaneous puncture in complex anatomical regions, including lung nodule biopsy and tumor ablation, and can be extended to other interventional procedures requiring high accuracy.
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