Ignite Creation Date:
2024-07-17 @ 11:09 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484764
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2024-06-26
Brief Title:
Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Biopsy Procedure
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
Validate the Feasibility and Safety of the Robot System by Comparing the CT-fluoroscopy Guidance Versus CT-guided Freehand Needle Biopsy in Participants With Suspected Thoracic or Abdominal Lesions in a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-07
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 multicenter randomized controlled trial aims to investigate whether the interventional robot can be well and safely used for percutaneous needle biopsy compared with the freehand needle biopsy method under CT guidance in patients with suspected thoracic or abdominal lesions The robot allows radiologists to remotely control the needle insertion process under the CT-fluoroscopy guidance The main questions it aims to answer are
1 Whether the robot-assisted needle biopsy method can decrease patient radiation exposure during the biopsy procedure
2 Whether the robot-assisted needle biopsy method can improve the success rate for radiologists to insert the needle into the target lesions area without additional needle adjustment
3 Whether the robot-assisted needle biopsy method can decrease the patients complication occurrence rate
4 Whether the robot-assisted needle biopsy method can decrease the time from the beginning to the end of needle insertion
All the participants with suspected thoracic and abdominal lesions will be randomly assigned to the study group or control group
Participants in the study group will receive a robot-assisted biopsy procedure under the CT-fluoroscopy guidance
Participants in the control group will receive a freehand needle biopsy under the CT guidance
1 Whether the robot-assisted needle biopsy method can decrease patient radiation exposure during the biopsy procedure
2 Whether the robot-assisted needle biopsy method can improve the success rate for radiologists to insert the needle into the target lesions area without additional needle adjustment
3 Whether the robot-assisted needle biopsy method can decrease the patients complication occurrence rate
4 Whether the robot-assisted needle biopsy method can decrease the time from the beginning to the end of needle insertion
All the participants with suspected thoracic and abdominal lesions will be randomly assigned to the study group or control group
Participants in the study group will receive a robot-assisted biopsy procedure under the CT-fluoroscopy guidance
Participants in the control group will receive a freehand needle biopsy under the CT guidance
Detailed Description:
Cancer has become the second main death reason among Chinese residents According to the latest global cancer burden data for 2020 released by the International Agency for Research on Cancer IARC of the World Health Organization there were 457 million new cases of cancer and more than 3 million deaths in China in 2020 accounting for 237 and 302 respectively of the total number of global cancer incidence and deaths in 2020 Early detection and early treatment have become crucial to reducing cancer incidence and mortality Image-guided percutaneous needle biopsy has been an important and established method for tumour treatment and diagnosis More specifically physicians under CT MRI magnetic resonance imaging or ultrasound guidance manually insert a puncture needle into the target area of the soft tissue lesion for biopsy However the image-guidance freehand biopsy method still faces the following challenges
1 Lack of real-time and accurate information during the needle insertion process including puncture force needle deformation soft tissue deformation and needle arrival position
2 Multiple scans during the puncture are needed to determine whether the needle has successfully reached the target area which leads to prolonged operation time easily induces complications and increases the radiation dose to the physicians
3 The accuracy of needle insertion is highly affected by the patients respiration movement causing the multi-directional nonlinear displacement and deformation of tissues and organs movement rotation etc resulting in the drift of the tumour position Eventually it is difficult for radiologists to insert the target position resulting in false negative results of biopsy or procedure failure
4 The physiological trembling of the radiologists hand will reduce the accuracy of puncture and even lead to complications such as bleeding and pneumothorax
5 Percutaneous puncture procedure is highly dependent on the ability and experience of radiologists
Here the investigators aim to evaluate whether the robot-assisted needle biopsy method can solve these challenges by comparing the safety and feasibility of robotic-assisted percutaneous needle biopsy with freehand needle biopsy
1 Lack of real-time and accurate information during the needle insertion process including puncture force needle deformation soft tissue deformation and needle arrival position
2 Multiple scans during the puncture are needed to determine whether the needle has successfully reached the target area which leads to prolonged operation time easily induces complications and increases the radiation dose to the physicians
3 The accuracy of needle insertion is highly affected by the patients respiration movement causing the multi-directional nonlinear displacement and deformation of tissues and organs movement rotation etc resulting in the drift of the tumour position Eventually it is difficult for radiologists to insert the target position resulting in false negative results of biopsy or procedure failure
4 The physiological trembling of the radiologists hand will reduce the accuracy of puncture and even lead to complications such as bleeding and pneumothorax
5 Percutaneous puncture procedure is highly dependent on the ability and experience of radiologists
Here the investigators aim to evaluate whether the robot-assisted needle biopsy method can solve these challenges by comparing the safety and feasibility of robotic-assisted percutaneous needle biopsy with freehand needle biopsy
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