Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Lung Cryablation Procedures
NCT Number: NCT06581107
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer|Thoracic Cancer
Interventions: PROCEDURE: CT-fluoroscopy guided master-slave intervetional robot-assisted lung Cryoablation
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Collaborators: Wuhan United Imaging Surgical co., ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2025-02-28
Locations: Tianjin Medical University, Cancer Institute & Hospital, Tianjin, Tianjin, 300060, China

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.

Primary Outcome Measures: Technical success rate, After the cryoablation procedure, the radiologists evaluate the consistency of the postoperative ablation area derived from the immediate postoperative thoracic CT scan with the size of the preoperative planning area. If consistent, it is defined as a technical success. The technical success rate is defined as the ratio of the number of participants with technical success to the total number of enrolled participants., The day of the procedure
Secondary Outcome Measures: The number of needle adjustments, The number will be counted when the needle tip angle is altered or the needle is retracted during the procedure., The day of the procedure|Number of cryoprobes used, The number of cryoprobes used to complete cryoablation for a single target lesion during the cryoablation procedure., The day of the procedure|Puncture time, Time from when the needle tip enters the skin to the completion of the puncture., The day of the procedure|Ablation time, Time for the single lesion from when the cryoprobe arrives at the target to when the investigator judges the cryoablation is completed., The day of the procedure|Procedure time, Time from when the patient is positioned to the completion of the ablation procedure as judged by the investigator., The day of the procedure|Evaluation of system performance, Subjective evaluation from the radiologists regarding the commonly used functions, operation, stability, and convenience of the research device., The day of the procedure|Compliations, Complications including pneumothorax, hemoptysis, bleeding, and other rare complications., 7±1 days postoperatively/on the day of discharge (whichever comes first).