NCT05451160

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	steep pulse therapy system	The steep pulse therapy system is produced by Zhejiang CuraWay Medical Technology Co., Ltd. for liver tumor ablation
DEVICE	RF Ablation System	RF Ablation System

Timeline

• Start date: 2022-03-16
• Primary completion: 2022-09-30
• Completion: 2022-12-31
• First posted: 2022-07-11
• Last updated: 2022-07-11

Locations

1 site across 1 country: China