A Multicenter, Randomized, Parallel-controlled Clinical Trial Protocol to Validate the Safety and Efficacy of a Steep Pulse Therapy System for the Treatment of Liver Tumors

Study Overview
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Brief Summary
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This clinical trial is a multicenter, randomized, parallel-controlled study. In this study, patients with liver cancer were selected as the research subjects, and the subjects were randomly divided into the experimental group and the control group. The experimental group used the steep pulse treatment system produced by Zhejiang CuraWay Medical Technology Co., Ltd., and the control group used the RF Ablation System produced by Covidien llc. A total of 5 or 9 visits were planned in this study, namely the screening period (-14-0 days), the day of the first ablation, 2 ± 1 days after the first ablation, 30 ± 5 days after the first ablation, and after the first ablation 90±7 days, the day of secondary ablation, 2±1 days after secondary ablation, 30±5 days after secondary ablation, and 90±7 days after secondary ablation. The complete ablation rate at 30 ± 5 days after the first ablation was used as the main efficacy evaluation index to evaluate the safety and efficacy of the steep pulse therapy system produced by Zhejiang CuraWay Medical Technology Co., Ltd. for liver tumor ablation.

Official Title
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A Multicenter, Randomized, Parallel-controlled Clinical Trial Protocol to Validate the Safety and Efficacy of a Steep Pulse Therapy System for the Treatment of Liver Tumors

Conditions
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A Steep Pulse Therapy System for the Treatment of Liver Tumors

Intervention / Treatment
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* Device: steep pulse therapy system
* Device: RF Ablation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age of the patient is between 18-80 years old, and the gender is not limited. For clinically diagnosed liver tumors, the diameter of a single tumor is less than or equal to 5cm; for multiple tumors: the number of tumors is not more than 3, and the largest tumor diameter is less than or equal to 3cm. Patient is able to take care of himself, and ECOG performance status is between 0 and 2 points. Liver function classification Child-Pugh A or B. Expected survival period ≥ 6 months. Patient is able to understand and comply with the trial protocol, and sign the informed consent. Exclusion Criteria: It is less than 30 days after the end of chemotherapy, radiotherapy, immunotherapy, or targeted therapy. Within 3 months after ablation, patients need to continue treatment with chemotherapy, radiation therapy, immunotherapy, targeted therapy, surgery, or other minimally invasive modalities. patients with severe infectious diseases such as bacteremia and toxemia. patients with uncorrectable coagulation dysfunction (PLT<40xl09/L). patients with severe heart, brain, lung and other diseases, and patients with severe arrhythmia. patients with implanted artificial hearts, lungs, internal pulse regulators or wearable medical electronic devices such as electrocardiography. Patients with a history of epilepsy. Patients with acute myocardial infarction within 6 months. Pregnant and lactating women and those who plan to become pregnant within one year. Those who are allergic to ultrasound, CT or MRI contrast agents. Those who are contraindicated in general anesthesia. Those who have participated in clinical trials of any drug or medical device within the first 3 months of the group. The researchers believe that there are other factors that are not suitable for inclusion or that affect the participation of subjects in the study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steep Pulse Therapy System<br> | Device: steep pulse therapy system<br>* The steep pulse therapy system is produced by Zhejiang CuraWay Medical Technology Co., Ltd. for liver tumor ablation<br>|
| Active Comparator: RF Ablation System<br> | Device: RF Ablation System<br>* RF Ablation System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day complete ablation rate | Complete ablation rate | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total complete ablation rate |  | 90 days | 
| Success rate of puncture |  | 1 day | 
| Equipment failure rate |  | 1 day |