Navigational Positioning System for Puncture Surgery
DeviceSuitable for puncture surgery navigation and localization systems to assist in the procedure
NCT Number: NCT07105813
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
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Suitable for puncture surgery navigation and localization systems to assist in the procedure
Time frame: Perioperative/Periprocedural
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.
Time frame: Perioperative/Periprocedural
Time frame: Perioperative/Periprocedural
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.
Time frame: Perioperative/Periprocedural
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.
Time frame: Perioperative/Periprocedural
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.
Time frame: Perioperative/Periprocedural
Time frame: Perioperative/Periprocedural
Time frame: Perioperative/Periprocedural
Time frame: Perioperative/Periprocedural
Xiaolong Yan, Dr.
Other
A Clinical Trial of the Safety and Efficacy of a Perforated Surgical Navigation and Localization System for Use in Percutaneous Pulmonary Ablation of Multiple Ground-glass Nodules
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