NCT06195917

Robotic-assisted Percutaneous Transhepatic Puncture

Evaluation of the Safety, Effectiveness and Usability of Robotic-assisted Interventional Percutaneous Transhepatic Puncture: A First-in-human Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Liver Diseases

Interventions

Type	Name	Description
DEVICE	Robotic-assisted Interventional Percutaneous transhepatic puncture	Robotic-assisted Interventional Percutaneous transhepatic puncture

Timeline

• Start date: 2023-09-19
• Primary completion: 2024-04-30
• Completion: 2024-05-01
• First posted: 2024-01-08
• Last updated: 2024-04-19

Locations

1 site across 1 country: China