A Clinical Trial of Percutaneous Lung Ablation Using Navigational Positioning Robot-assisted Proc… (NCT07105813) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Trial of Percutaneous Lung Ablation Using Navigational Positioning Robot-assisted Procedures
30 participantsStarted 2025-09-15
Plain-language summary
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
Who can participate
Age range18 Years – 80 Years
SexALL
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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:
✓. Cannot tolerate surgical resection due to poor cardiopulmonary function or advanced age;
✓. Refuse to undergo surgical resection;
✓. Residual lesions or new lesions after surgical resection;
✓. Severe pleural adhesions or pleural cavity atresia from various causes;
✓. Single lung (absence of one side of the lung from various causes);
Exclusion criteria
✕. Those with skin redness, swelling, broken skin, symptoms of skin diseases at the puncture site, dermatologic diseases that cannot be affixed with markers, or acute suppurative infections in the pleural cavity;
✕. Platelets \<50 × 109/L, or severe bleeding tendency, coagulation dysfunction that cannot be corrected in a short period of time (prothrombin time \>18 s, plasminogen activity \<40%), or anticoagulant therapy and/or antiplatelet drugs that have not been discontinued for more than 5 d to 7 d prior to ablation, and the interval between the last use of bevacizumab has not exceeded 1 month;
✕. Those with severe systemic infection and high fever (\>38.5°C);
✕. Lung nodules close to important organs such as mediastinum or cardiac great vessels;
✕. Those who have other diseases such as pulmonary pustules or pulmonary cysts leading to pneumothorax in the proposed puncture path, or those who have obvious infectious lesions in the puncture path;
✕. Those with poorly controlled pleural effusion;
✕. Severe pulmonary fibrosis and pulmonary hypertension;
✕. Those with severe cardiac, hepatic, pulmonary, renal, or cerebral insufficiency;