This is a first-in-man study to investigate the feasibility and safety profile of the newly developed robotic system for percutaneous transhepatic interventional procedures, including biopsy and ablation. Participants who were clinically assessed in need of a liver lesion puncture were included in this study.
In current clinical practice, surgeons mainly use personal experience as a judgment criterion to determine the insertion Angle and trajectory of the needle path. In the process of puncture surgery, surgeons will complete the positioning puncture in three-dimensional space based on the guidance of two-dimensional images and personal judgment. Among them, the lack of three-dimensional sense of space in two-dimensional images may cause inaccurate positioning of the puncture needle in three-dimensional space, and even lead to the deviation of the needle tip approach, resulting in inaccurate biopsy sampling or inaccurate anastomosis in the simulation of thermal field before ablation. In addition, during surgery, changes in the patient's own gravity, breathing movements, posture, or the application of force during needle insertion may cause soft tissue displacement, thereby reducing the accuracy of positioning. In general, in order to ensure the accuracy of puncture, doctors will insert needles repeatedly and perform multiple CT scans on patients, which will lead to low surgical efficiency, increased risk of puncture complications, and increased trauma and pain of patients. In addition, in the puncture operation for liver tumors, if the needle insertion path is not accurate and the needle path is adjusted repeatedly, the risk of the puncture needle carrying out tumor cells will increase, which may cause the metastasis and spread of cancer cells, which is also a big challenge for young doctors. The investigators aim to evaluate the safety, effectiveness and usability of robotic-assisted percutaneous transhepatic puncture in this prospective study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Robotic-assisted Interventional Percutaneous transhepatic puncture
Centre of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
RECRUITINGOne-time puncture success rate
One-time puncture success rate is defined as the rate of one-time of successful percutanoues transhepatic puncture
Time frame: one day
Number of puncture attempts
Number of puncture attempts was defined as the total number of punctures until the puncture success
Time frame: one day
Puncture accuracy
Puncture accuracy was defined as the Euclidean distance to the pre-defined target
Time frame: one day
Planning time
Time from completion of the first CT scan to successful surgical planning of the target lesion
Time frame: one day
Instrument performance evaluation
The performance of the system was evaluated by investigators, including system display stability evaluation,evaluation of maneuverability and stability of surgical planning cart, evaluation of operation and stability of central control platform,evaluation of maneuverability and stability of optical tracking vehicle,evaluation of maneuverability and stability of robotic manipulator.
Time frame: one day
Incidence of adverse events
Safety of the device will be evaluated by reporting the incidence, severity and frequency of all Adverse Events (AE), related and unrelated to the device treatment.
Time frame: three days
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