Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06195917
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-12-07
Brief Title:
Robotic-assisted Percutaneous Transhepatic Puncture
Sponsor:
Zhongda Hospital
Organization:
Zhongda Hospital
Study Overview
Official Title:
Evaluation of the Safety Effectiveness and Usability of Robotic-assisted Interventional Percutaneous Transhepatic Puncture A First-in-human Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None