Various liver diseases requiring biopsy or ablation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Participants must be 18 years of age or older, with no gender restrictions. (2) Participants must be clinically assessed and deemed in need of a liver lesion puncture by the researcher. (3) Liver lesions with a diameter greater than or equal to 1 cm are eligible for inclusion. (4) Participants must have liver function graded as either Child-Pugh Class A or Class B. (5) Participants must voluntarily agree to participate in this clinical trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Individuals 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) Individuals with severe coagulation disorders during the screening period, characterized by a platelet count 6s, and an international normalized ratio (INR) > 1.5. (3) Individuals classified as NYHA heart function Grade III and IV during the screening period. (4) Individuals with severe chronic obstructive pulmonary disease (COPD) or severe asthma during the screening period. (5) Individuals 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) Individuals who are unable to cooperate with surgical positioning and other requirements for surgery. (7) Pregnant or lactating women of childbearing age and other vulnerable groups. (8) Individuals who 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First attempt success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Localization puncture success rate;Number of puncture attempts;Puncture accuracy;Puncture surgery planning time;Instrument performance evaluation; | — |
Countries
China
Contacts
Lishui Municipal Central Hospital