Robotic-assisted liver lesion puncture procedure

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

This study is testing a new robotic system to see if it can make liver lesion procedures safer and more accurate for patients who need them.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhongda Hospital (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06195917 on ClinicalTrials.gov

What this trial studies

This study investigates the feasibility and safety of a newly developed robotic system designed for percutaneous transhepatic interventional procedures, such as biopsy and ablation of liver lesions. The current method relies heavily on the surgeon's experience and two-dimensional imaging, which can lead to inaccuracies in needle positioning. By utilizing a robotic system, the study aims to improve the precision of needle insertion, reduce the number of attempts needed, and minimize patient trauma and complications. Participants in need of a liver lesion puncture will be included in this first-in-man study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with clinically assessed liver lesions of at least 1 cm in diameter and Child-Pugh Class A or B liver function.

Not a fit: Patients with severe liver cirrhosis, coagulation disorders, or significant respiratory or renal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the accuracy and safety of liver lesion punctures, leading to better patient outcomes.

How similar studies have performed: While this approach is novel, similar robotic-assisted techniques in other surgical fields have shown promising results.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• Centre of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Southeast University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Jian Lu, MD — Zhongda Hospital
• Study coordinator: Jian Lu, MD

Conditions Liver Diseases