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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

Primary Purpose

A Steep Pulse Therapy System for the Treatment of Liver Tumors

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

steep pulse therapy system

RF Ablation System

About this trial

This is an interventional treatment trial for A Steep Pulse Therapy System for the Treatment of Liver Tumors

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The First Affiliated Hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Steep Pulse Therapy System

RF Ablation System

Arm Description

Outcomes

Primary Outcome Measures

30-day complete ablation rate

Complete ablation rate

Secondary Outcome Measures

Total complete ablation rate

Success rate of puncture

Equipment failure rate

Full Information

NCT ID

NCT05451160

First Posted

July 6, 2022

Last Updated

July 8, 2022

Sponsor

First Affiliated Hospital of Zhejiang University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05451160

Brief Title

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

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 16, 2022 (Actual)

Primary Completion Date

September 30, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital of Zhejiang University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

A Steep Pulse Therapy System for the Treatment of Liver Tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Steep Pulse Therapy System

Arm Type

Experimental

Arm Title

RF Ablation System

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

steep pulse therapy system

Intervention Description

The steep pulse therapy system is produced by Zhejiang CuraWay Medical Technology Co., Ltd. for liver tumor ablation

Intervention Type

Device

Intervention Name(s)

RF Ablation System

Intervention Description

RF Ablation System

Primary Outcome Measure Information:

Title

30-day complete ablation rate

Description

Complete ablation rate

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Total complete ablation rate

Time Frame

90 days

Title

Success rate of puncture

Time Frame

1 day

Title

Equipment failure rate

Time Frame

1 day

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tian'an Jiang, PhD.

Phone

+8618857127666

tiananjiang@zju.edu.cn

Facility Information:

Facility Name

The First Affiliated Hospital of Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tian'an Jiang, Phd

Phone

+86 18857127666

tiananjiang@126.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33724066

Citation

Meijerink MR, Ruarus AH, Vroomen LGPH, Puijk RS, Geboers B, Nieuwenhuizen S, van den Bemd BAT, Nielsen K, de Vries JJJ, van Lienden KP, Lissenberg-Witte BI, van den Tol MP, Scheffer HJ. Irreversible Electroporation to Treat Unresectable Colorectal Liver Metastases (COLDFIRE-2): A Phase II, Two-Center, Single-Arm Clinical Trial. Radiology. 2021 May;299(2):470-480. doi: 10.1148/radiol.2021203089. Epub 2021 Mar 16.

Results Reference

background

PubMed Identifier

35210014

Citation

Su GL, Altayar O, O'Shea R, Shah R, Estfan B, Wenzell C, Sultan S, Falck-Ytter Y. AGA Clinical Practice Guideline on Systemic Therapy for Hepatocellular Carcinoma. Gastroenterology. 2022 Mar;162(3):920-934. doi: 10.1053/j.gastro.2021.12.276.

Results Reference

result

PubMed Identifier

34239808

Citation

Kudo M, Kawamura Y, Hasegawa K, Tateishi R, Kariyama K, Shiina S, Toyoda H, Imai Y, Hiraoka A, Ikeda M, Izumi N, Moriguchi M, Ogasawara S, Minami Y, Ueshima K, Murakami T, Miyayama S, Nakashima O, Yano H, Sakamoto M, Hatano E, Shimada M, Kokudo N, Mochida S, Takehara T. Management of Hepatocellular Carcinoma in Japan: JSH Consensus Statements and Recommendations 2021 Update. Liver Cancer. 2021 Jun;10(3):181-223. doi: 10.1159/000514174. Epub 2021 May 19.

Results Reference

result

PubMed Identifier

32978054

Citation

Ruarus AH, Barabasch A, Catalano O, Leen E, Narayanan G, Nilsson A, Padia SA, Wiggermann P, Scheffer HJ, Meijerink MR. Irreversible Electroporation for Hepatic Tumors: Protocol Standardization Using the Modified Delphi Technique. J Vasc Interv Radiol. 2020 Nov;31(11):1765-1771.e15. doi: 10.1016/j.jvir.2020.02.030. Epub 2020 Sep 22.

Results Reference

result

PubMed Identifier

34057003

Citation

Freeman E, Cheung W, Ferdousi S, Kavnoudias H, Majeed A, Kemp W, Roberts SK. Irreversible electroporation versus radiofrequency ablation for hepatocellular carcinoma: a single centre propensity-matched comparison. Scand J Gastroenterol. 2021 Aug;56(8):942-947. doi: 10.1080/00365521.2021.1930145. Epub 2021 May 30.

Results Reference

result

Learn more about this trial

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

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