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 NA Last updated 11 July 2022

What this trial tests

NA trial testing steep pulse therapy system in A Steep Pulse Therapy System for the Treatment of Liver Tumors in 180 participants. Status unknown.

Timeline

16 March 2022

Primary endpoint
30 September 2022

31 December 2022

Quick facts

Lead sponsor	First Affiliated Hospital of Zhejiang University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	180
Start date	16 March 2022
Primary completion	30 September 2022
Estimated completion	31 December 2022
Sites	1 location across China

Drugs / interventions tested

• steep pulse therapy system
• RF Ablation System

Conditions studied

• A Steep Pulse Therapy System for the Treatment of Liver Tumors — all drugs for A Steep Pulse Therapy System for the Treatment of Liver Tumors →

Sponsor

First Affiliated Hospital of Zhejiang University

Who can join

Eligibility, any sex, with A Steep Pulse Therapy System for the Treatment of Liver Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A multicenter, randomized, parallel-controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of small hepatocellular carcinoma.
   Cheng C, Xu M, Pan J, Chen Q, et al · · 2024 · cited 4× · PMID 39707376 · DOI 10.1186/s12957-024-03614-z
2. A multicenter, randomized, parallel-controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of hepatocellular carcinoma
   Pan J, Xu M, Li K, Xu D, et al · · 2023 · DOI 10.21203/rs.3.rs-2897431/v1