Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wuhan United Imaging Surgical co., ltd. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Singel arm | Experimental | CT-fluoroscopy guided robot-assisted percutaneous lung Cryoablation group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-fluoroscopy guided master-slave intervetional robot-assisted lung Cryoablation | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haipeng Yu, PhD | Contact | 0086-22-23340123 | jieruke@163.com | |
| Xueling Yang, PhD | Contact | 0086-22-23340123 | yxueling123@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenge Xing, Professor | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University, Cancer Institute & Hospital | Tianjin | Tianjin Municipality | 300060 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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). |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided