Robotic-assisted Percutaneous Transhepatic Puncture

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.

Eligibility

Inclusion Criteria:

1. 18 years of age or older, with no gender restrictions. (2) clinically assessed and deemed in need of a liver lesion puncture. (3) with a intrahepatic lesion no less than 1 cm in diameter. (4)with liver function of Child-Pugh Class A or B. (5) agree to participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

1. with severe liver cirrhosis or in a decompensated liver function state within the 3 months prior to screening and who have undergone abdominal paracentesis for the treatment of a large amount of ascites.
2. with severe coagulation disorders during the screening period, characterized by a platelet count \< 50×10\^9/L, a prolonged PT time \> 6s, and an international normalized ratio (INR) \> 1.5.
3. classified as NYHA heart function Grade III and IV during the screening period.
4. with severe chronic obstructive pulmonary disease (COPD) or severe asthma during the screening period.
5. with renal insufficiency during the screening period, defined by creatinine (Cr) or blood urea nitrogen (BUN/UREA) levels exceeding two times the upper limit of normal.
6. unable to cooperate with surgical positioning and other requirements for surgery.
7. Pregnant or lactating women of childbearing age and other vulnerable groups.
8. have participated in other interventional clinical trials within the month prior to the commencement of this trial.
9. Other individuals who are deemed unsuitable for participation in this trial by the investigator.

Conditions2

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