Clinical trial · Interventional
NeuWave Microwave Ablation HCC China Study
A Single-Arm, Prospective, Multicenter Study to Evaluate the Safety and Effectiveness of the NeuWave Certus Microwave Ablation System in Chinese Patients With Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Tumor | Liver Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microwave ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single-arm
- description
- Subjects will be treated with microwave ablation.
- interventionNames
- Device: Microwave ablation
Primary outcomes (1)
- measure
- Technical Efficacy
- timeFrame
- Day 23 to Day 37
- description
- 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.
Secondary outcomes (4)
- measure
- Technical Success
- timeFrame
- Day 0 to Day 7
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: 1. ASA score ≥ 4. 2. Active bacterial or fungal infections which are clinically significantly. 3. Chemotherapy or radiation therapy for HCC performed within 30 days prior to the study procedure. 4. Patient with implantable pacemakers or other electronic implants. 5. Planned/ scheduled liver surgery. 6. Platelet count ≤ 50 × 109/L. 7. 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). 8. Patient with renal failure and on renal dialysis. 9. Scheduled concurrent procedure other than MW ablation in the liver. 10. Pregnant or breast feeding. 11. Physical or psychological condition which would impair study participation. 12. Participation in any other interventional clinical study within 1 month before screening and concurrently during the study. 13. The patient is judged unsuitable for study participation by the investigator for any other reason.
References
Publications (0)
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