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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Robotic-assisted Interventional Percutaneous transhepatic puncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted Interventional Percutaneous transhepatic puncture | Device | Robotic-assisted Interventional Percutaneous transhepatic puncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| One-time puncture success rate | One-time puncture success rate is defined as the rate of one-time of successful percutanoues transhepatic puncture | one day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of puncture attempts | Number of puncture attempts was defined as the total number of punctures until the puncture success | one day |
| Puncture accuracy | Puncture accuracy was defined as the Euclidean distance to the pre-defined target |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Lu, MD | Contact | +8615850654644 | lujian43307131@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Lu, MD | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| one day |
| Planning time | Time from completion of the first CT scan to successful surgical planning of the target lesion | 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. | 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. | three days |