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The purpose of the trial is to exploratively evaluate the safety and efficacy of the Puncture Surgery Navigation and Positioning System for CT-guided percutaneous lung ablation procedures for multiple ground glass nodules.
Thirty subjects are planned to be enrolled in this study. In the study, it is planned to perform CT-guided percutaneous lung ablation procedures in the enrolled patients using the Puncture Surgery Navigation and Positioning System, and to evaluate the technical success rate, puncture accuracy, one-time technical success rate, one-needle penetration in place, number of needle adjustments, time to puncture, and complication rate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigational Positioning System for Puncture Surgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigational Positioning System for Puncture Surgery | Device | Suitable for puncture surgery navigation and localization systems to assist in the procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Researchers successfully completed percutaneous ablation surgery using a robotic system. If there were no major needle adjustments during the procedure and no instrument defects or mechanical arm collisions occurred, the technique can be deemed successful. | Perioperative/Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of cases where puncture is successful after one puncture or fine adjustment | Perioperative/Periprocedural | |
| One technical success rate | A technical success is defined as the achievement of technical success with a single needle puncture or minor adjustments. One technical success rate is the percentage of technical success cases in the total number of cases. |
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Inclusion Criteria:
Age ≥18 years and <80 years, regardless of sex;
Diagnosis of persistent multiple pulmonary ground glass nodules (GGN), including pure ground glass nodules (pGGN) and mixed ground glass nodules (mGGN), with no limitation on the size and number of nodules, where persistence is defined as the non-resolution of the GGN after 3 months of follow-up after detection;
Patients who are evaluated as needing treatment for a primary or secondary lesion of a ground glass nodule in the lung, and the diameter of the lesion to be ablated is ≥6.0 mm, and who meet any of the following can be enrolled:
The patient fully understands the benefits and risks of this trial, is willing to participate in the trial and signs an informed consent form.
Exclusion Criteria:
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| Perioperative/Periprocedural |
| One-needle puncture placement rate | After the needle is inserted according to the pre-planned puncture direction, angle, and depth, a CT scan is performed to observe the positional relationship between the needle tip and the lung nodule. If the proposed ablation range at the needle tip position can surround the lung nodule by 5-10 mm, the researcher determines that no needle adjustment is necessary and that the ablation procedure can continue, thus confirming that the needle is in the correct position. The one-needle puncture success rate is the proportion of punctures that are successful on the first attempt. | Perioperative/Periprocedural |
| Complete ablation rate | By measuring whether the post-ablation GGO exceeds the pre-ablation GTR boundary by 5-10 mm on the post-ablation CT image, it is determined whether complete ablation has been achieved. | Perioperative/Periprocedural |
| Number of needle adjustments | Perioperative/Periprocedural |
| puncture duration | Perioperative/Periprocedural |
| Adverse event rate | Perioperative/Periprocedural |
| Incidence of device defects | Perioperative/Periprocedural |