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

July 8, 2022 updated by: First Affiliated Hospital of Zhejiang University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The age of the patient is between 18-80 years old, and the gender is not limited.
  2. 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.
  3. Patient is able to take care of himself, and ECOG performance status is between 0 and 2 points.
  4. Liver function classification Child-Pugh A or B.
  5. Expected survival period ≥ 6 months.
  6. Patient is able to understand and comply with the trial protocol, and sign the informed consent.

Exclusion Criteria:

  1. It is less than 30 days after the end of chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
  2. Within 3 months after ablation, patients need to continue treatment with chemotherapy, radiation therapy, immunotherapy, targeted therapy, surgery, or other minimally invasive modalities.
  3. patients with severe infectious diseases such as bacteremia and toxemia.
  4. patients with uncorrectable coagulation dysfunction (PLT<40xl09/L).
  5. patients with severe heart, brain, lung and other diseases, and patients with severe arrhythmia.
  6. patients with implanted artificial hearts, lungs, internal pulse regulators or wearable medical electronic devices such as electrocardiography.
  7. Patients with a history of epilepsy.
  8. Patients with acute myocardial infarction within 6 months.
  9. Pregnant and lactating women and those who plan to become pregnant within one year.
  10. Those who are allergic to ultrasound, CT or MRI contrast agents.
  11. Those who are contraindicated in general anesthesia.
  12. Those who have participated in clinical trials of any drug or medical device within the first 3 months of the group.
  13. The researchers believe that there are other factors that are not suitable for inclusion or that affect the participation of subjects in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Steep Pulse Therapy System
Device: steep pulse therapy system
The steep pulse therapy system is produced by Zhejiang CuraWay Medical Technology Co., Ltd. for liver tumor ablation
ACTIVE_COMPARATOR: RF Ablation System
Device: RF Ablation System
RF Ablation System

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Collaborators

Zhejiang Cancer Hospital
West China Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Tianjin Third Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 16, 2022

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

July 8, 2022

First Posted (ACTUAL)

July 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • steeppulse001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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