Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581107
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Lung Cryablation Procedures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validate the Feasibility and Safety of the Robot System by Investgating the CT-fluoroscopy Guidance in Percutaneous Lung Cryablation Procedures of Participants With Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to investigate whether the interventional robot can be well and safely used for percutaneous lung cryoablation in patients with lung cancer The robot allows radiologists to remotely control the needle insertion process under CT fluoroscopy guidance
The main questions this study aims to answer are
1 Whether the robot-assisted Cryoablation method can achieve complete the coverage of preoperatively planned ablation areas
2 Whether the robot-assisted Cryoablation method can improve the success rate for radiologists to insert the needle into the target lesion area without additional needle adjustment
3 Whether the robot-assisted Cryoablation method can reduce puncture time ablation time and procedure time
4 Whether the robot-assisted Cryoablation method can decrease the patients complication occurrence rate
5 Whether the robot-assisted Cryoablation method can obtain decent Evaluation of system performance
The main questions this study aims to answer are
1 Whether the robot-assisted Cryoablation method can achieve complete the coverage of preoperatively planned ablation areas
2 Whether the robot-assisted Cryoablation method can improve the success rate for radiologists to insert the needle into the target lesion area without additional needle adjustment
3 Whether the robot-assisted Cryoablation method can reduce puncture time ablation time and procedure time
4 Whether the robot-assisted Cryoablation method can decrease the patients complication occurrence rate
5 Whether the robot-assisted Cryoablation method can obtain decent Evaluation of system performance
Detailed Description:
Lung cancer is the leading cause of morbidity and mortality of malignant tumors
The surgical resection of lung lobes is the standard treatment for stage I non-small cell lung cancer NSCLC with proven long-term cure rates and survival However more than 20 of patients are not eligible for surgical treatment due to comorbidities or poor underlying lung reserve
With the development of minimally invasive interventional field lung cancer cryoablation has also become an established tool for the treatment of early stage lung cancer and palliative treatment of advanced lung cancer in recent years
However the image-guidance cryoablation 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 reach the target position resulting in insufficient ablation areas and increased probability of cancer recurrence
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 The procedure is highly dependent on the ability and experience of radiologists
The surgical resection of lung lobes is the standard treatment for stage I non-small cell lung cancer NSCLC with proven long-term cure rates and survival However more than 20 of patients are not eligible for surgical treatment due to comorbidities or poor underlying lung reserve
With the development of minimally invasive interventional field lung cancer cryoablation has also become an established tool for the treatment of early stage lung cancer and palliative treatment of advanced lung cancer in recent years
However the image-guidance cryoablation 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 reach the target position resulting in insufficient ablation areas and increased probability of cancer recurrence
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 The procedure is highly dependent on the ability and experience of radiologists
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None