NeuWave Microwave Ablation HCC China Study

NCT03783871 | Completed Results FDA Device

• 1 other identifier: NEU_2017_07
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 4

Brief Summary

This is a single-arm, prospective, multicenter, study. Individuals who are assessed for microwave (MW) ablation of HCC in accordance with their institution's standard of care (SOC), who meet study entry criteria and sign the informed consent, will be enrolled. The patients will be treated with MW ablation and afterwards followed for up to 36 months after the original ablation procedure to assess efficacy and safety. In addition to the final analysis after all enrolled patients complete the 36-month observation period, a summary of selected endpoints will be provided after all enrolled patients have completed each of the 1-month and 12-month visits. To provide sites with an opportunity to get equal experience in the use of the Certus system, there will 3 patients treated as part of a run-in phase. These patients will only be included in the safety set.

Conditions

Liver Tumor; Hepatocellular Carcinoma

Keywords

HCC

Outcome Measures

Primary Outcomes (1)

• Technical Efficacy

  Defined as a combination of A0 ablations (complete tumor ablation with a surrounding 5 mm margin) and A1 ablations ( complete tumor ablation with inadequate margins), based on contrast-enhanced MRI scans at 1 month (+/- 7 days) post-ablation.

  Day 23 to Day 37

Secondary Outcomes (4)

• Technical Success

  Day 0 to Day 7

• Local Tumor Progression

  1 Month to 36 Months

• Overall Survival

  36 months

• Progression-Free Survival

  36 months

Study Arms (1)

Single-arm

EXPERIMENTAL

Subjects will be treated with microwave ablation.

Device: Microwave ablation

Interventions

Microwave ablation DEVICE

Subjects will be treated with microwave ablation.

Single-arm

Eligibility Criteria

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

You may qualify if:

• Diagnosed primary or recurrent HCC determined in accordance with the institution's SOC procedure, a single tumor size up to 5 cm or a maximum of 3 tumors up to 3 cm per tumor. Tumor size must be measured with at least 2-dimensional (2D) imaging.
• Scheduled for microwave ablation of the liver.
• Performance status 0-2 (Eastern Cooperative Oncology Group classification).
• Functional hepatic reserve based on the Child-Pugh score (Class A or B).
• Give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule.
• At least 18 years of age.

You may not qualify if:

• ASA score ≥ 4.
• Active bacterial or fungal infections which are clinically significantly.
• Chemotherapy or radiation therapy for HCC performed within 30 days prior to the study procedure.
• Patient with implantable pacemakers or other electronic implants.
• Planned/ scheduled liver surgery.
• Platelet count ≤ 50 × 109/L.
• Patients with uncorrectable coagulopathy at time of screening based on investigator judgement. Severe blood coagulation dysfunction (bleeding tendency, prothrombin time \[PT\] was greater than normal control for 3\~5 seconds, platelet count \[PLT\] was less than 50x109/L, and the international normalized ratio \[INR\] was greater than 1.5).
• Patient with renal failure and on renal dialysis.
• Scheduled concurrent procedure other than MW ablation in the liver.
• Pregnant or breast feeding.
• Physical or psychological condition which would impair study participation.
• Participation in any other interventional clinical study within 1 month before screening and concurrently during the study.
• The patient is judged unsuitable for study participation by the investigator for any other reason.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (4)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital，Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Chinese PLA General Hospital

Beijing, 100089, China

Location

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200120, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Erin Meyers
• Organization: Ethicon

eprifog1@its.jnj.com

937-681-0322

Study Officials

• Ping Liang, Doctor

  Leading PI

  PRINCIPAL INVESTIGATOR

• Jinhua Huang, Doctor

  Co-PI

  PRINCIPAL INVESTIGATOR

• Xiaoyan Xie, Doctor

  Co-PI

  PRINCIPAL INVESTIGATOR

• Bo Zhai, Doctor

  CO-PI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 21, 2018
• Study Start: February 18, 2019
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: April 25, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-04

Locations

CN (4)