Effectiveness safety and feasibility of the broadband collaborative pulse ablation instrument in treating malignant pulmonary nodules
This clinical trial is to observe the safety and efficacy of the broadband synergistic pulse ablation device for treating malignant pulmonary nodules, and to provide reference data for the development of formal trials.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Via CT guided, patients with malignant pulmonary nodules would be treated by broadband collaborative pulse ablation
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Ablation success rate
Ablation success rate = (numbers of nodule be completely ablated) / (numbers of nodule be ablated). Contrast-enhanced CT examination showed no significant enhancement of the nodule ablation area, and the nodule was considered to be completely ablated.
Time frame: 1 month after ablation
Nodule ablation time
The time taken for nodule ablation is recorded according to the time displayed by the ablation instrument
Time frame: Immediately after ablation
Complete ablation rate
Ablation success rate = (numbers of nodule be completely ablated) / (numbers of nodule be ablated). Contrast-enhanced CT examination showed no significant enhancement of the nodule ablation area, and the nodule was considered to be completely ablated
Time frame: 3 months after ablation
Nodule recurrence rate
Ablation recurrence rate = (numbers of nodule recurrence) / (numbers of nodule be ablated). Contrast-enhanced CT showed the presence of an enhancement foci within the area of nodule ablation, and the nodule was considered to be recurrence.
Time frame: 6 months after ablation
Adverse events
Adverse Events as assessed by NCI CTCAE V5.0 (Safety and Tolerability)
Time frame: Up to 6 months
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