Broadband Collaborative Pulse Ablation Instrument Treating Malignant Pulmonary Nodules
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Zhongshan Hospital
About this trial
Effectiveness safety and feasibility of the broadband collaborative pulse ablation instrument in treating malignant pulmonary nodules
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: between 18 and 70 years old with no gender limitation;
Malignant pulmonary nodules diagnosed by cytology and/or histopathology, or the number of tumors ≤3. The pulmonary nodules were oligometastatic and the primary lesions were stable, with no uncontrolled metastasis to other sites;
Surgery is not available or the patient refuses surgical treatment;
Nodules' Maximum diameter≤2cm;
Disqualifiers
An electronic device is implanted near the target area or an implanted pacemaker or defibrillator is present in the body;
Coagulation dysfunction with severe bleeding tendency and short-term correction (prothrombin time >18s, prothrombin activity <40%, platelet <80×109 /L);
Patient who can not stop taking Antiplatelet and anticoagulant drugs 5 days before surgery;
Severe pulmonary fibrosis and pulmonary hypertension;
Trial design
Design model
Single group
Treatments tested in this trial
broadband collaborative pulse ablation
DeviceVia CT guided, patients with malignant pulmonary nodules would be treated by broadband collaborative pulse ablation
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 ablationSecondary outcomes
1
Nodule ablation time
The time taken for nodule ablation is recorded according to the time displayed by the ablation instrument
Time frame
Immediately after ablation2
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 ablation3
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 ablation4
Adverse events
Adverse Events as assessed by NCI CTCAE V5.0 (Safety and Tolerability)
Time frame
Up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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