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

NCT05451160 | Unknown

• 1 other identifier: steeppulse001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

A Steep Pulse Therapy System for the Treatment of Liver Tumors

Outcome Measures

Primary Outcomes (1)

• 30-day complete ablation rate

  Complete ablation rate

  30 days

Secondary Outcomes (3)

• Total complete ablation rate

  90 days

• Success rate of puncture

  1 day

• Equipment failure rate

  1 day

Study Arms (2)

Steep Pulse Therapy System

EXPERIMENTAL

Device: steep pulse therapy system

RF Ablation System

ACTIVE COMPARATOR

Device: RF Ablation System

Interventions

steep pulse therapy system DEVICE

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

Steep Pulse Therapy System

RF Ablation System DEVICE

RF Ablation System

RF Ablation System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Zhejiang Cancer Hospital: collaborator
• West China Hospital: collaborator
• Tianjin Third Central Hospital: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 33724066 BACKGROUND

• 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.

  PMID: 35210014 RESULT

• 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.

  PMID: 34239808 RESULT

• 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.

  PMID: 32978054 RESULT

• 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.

  PMID: 34057003 RESULT

• Cheng C, Xu M, Pan J, Chen Q, Li K, Xu D, Jing X, Lu Q, Yang H, Zhao Q, Deng Z, Jiang T. 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. World J Surg Oncol. 2024 Dec 20;22(1):332. doi: 10.1186/s12957-024-03614-z.

  PMID: 39707376 DERIVED

Central Study Contacts

Tian'an Jiang, PhD.

CONTACT

+8618857127666; tiananjiang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: March 16, 2022
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)