NCT06581107

Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Lung Cryablation Procedures

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 patient's 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 patient's 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 radiologist's 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.

Conditions

• Lung Cancer
• Thoracic Cancer

Interventions

Type	Name	Description
PROCEDURE	CT-fluoroscopy guided master-slave intervetional robot-assisted lung Cryoablation	During the procedure, the participants first undergo a CT scan. The radiologist plans the trajectories based on the registered preoperative CECT (contrast-enhanced computed tomography) and intraoperative CT. All participants then undergo navigation, localization, and establishment of cryoprobe trajectories using the interventional master-slave system. On the day of the procedure, the number of needle adjustments, number of cryoprobes used, puncture time, ablation time, and procedure time are recorded. The performance of the research device is evaluated by the radiologists. Postoperative complications of the participants are recorded 7±1 days postoperatively/on the day of discharge based on the postoperative CT scan (whichever comes first).

Timeline

• Start date: 2024-09-15
• Primary completion: 2024-12-31
• Completion: 2025-02-28
• First posted: 2024-09-03
• Last updated: 2024-09-03

Locations

1 site across 1 country: China