N/A
Completed N=135
NeuWave Microwave Ablation HCC China Study
Source: ClinicalTrials.gov NCT03783871 ↗Enrolled (actual)
135
Serious AEs
31.1%
Results posted
Feb 2025
Primary outcomePrimary: Technical Efficacy — 107 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Technical Efficacy |
107 | — |
| SECONDARY Technical Success |
112 | — |
| SECONDARY Local Tumor Progression |
18 | — |
| SECONDARY Overall Survival |
13 | — |
| SECONDARY Progression-Free Survival |
81 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03783871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.