Status:
COMPLETED
NeuWave Microwave Ablation HCC China Study
Lead Sponsor:
Ethicon, Inc.
Conditions:
Liver Tumor
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ent...
Detailed Description
Patients who have a single HCC tumor up to 5 cm or a maximum of 3 HCC tumors of up to 3 cm per tumor will receive the same procedure: microwave ablation using only the NeuWave Certus Microwave Ablatio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2024
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT03783871
Start Date
February 18 2019
End Date
January 17 2024
Last Update
April 25 2025
Active Locations (4)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
2
The First Affiliated Hospital，Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
3
Chinese PLA General Hospital
Beijing, China, 100089
4
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200120