Robotic-assisted Percutaneous Transhepatic Puncture

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06195917
• Other study ID #: IRob-Zhongda001
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2024
• Source: Zhongda Hospital
• Contact: Jian Lu, MD
• Phone: +8615850654644
• Email: lujian43307131[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Device:
• Robotic-assisted Interventional Percutaneous transhepatic puncture
Robotic-assisted Interventional Percutaneous transhepatic puncture

Locations

Country	Name	City	State
China	Centre of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Number of puncture attempts	Number of puncture attempts was defined as the total number of punctures until the puncture success	one day
Secondary	Puncture accuracy	Puncture accuracy was defined as the Euclidean distance to the pre-defined target	one day
Secondary	Planning time	Time from completion of the first CT scan to successful surgical planning of the target lesion	one day
Secondary	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
Secondary	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