Robotic-assisted Percutaneous Transhepatic Puncture

NCT06195917 | Recruiting DMC

• 1 other identifier: IRob-Zhongda001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of puncture attempts

  one day

• Puncture accuracy

  one day

• Planning time

  one day

• Instrument performance evaluation

  one day

• Incidence of adverse events

  three days

Study Arms (1)

Experimental group

EXPERIMENTAL

Robotic-assisted Interventional Percutaneous transhepatic puncture

Device: Robotic-assisted Interventional Percutaneous transhepatic puncture

Interventions

Robotic-assisted Interventional Percutaneous transhepatic puncture DEVICE

Robotic-assisted Interventional Percutaneous transhepatic puncture

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• classified as NYHA heart function Grade III and IV during the screening period.
• with severe chronic obstructive pulmonary disease (COPD) or severe asthma during the screening period.
• 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.
• unable to cooperate with surgical positioning and other requirements for surgery.
• Pregnant or lactating women of childbearing age and other vulnerable groups.
• have participated in other interventional clinical trials within the month prior to the commencement of this trial.
• Other individuals who are deemed unsuitable for participation in this trial by the investigator.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Centre of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Jian Lu, MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Lu, MD

CONTACT

+8615850654644; lujian43307131@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 8, 2024
• Study Start: September 19, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 1, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)