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NeuWave Microwave Ablation HCC China Study
NA trial testing Microwave ablation in Liver Tumor in 135 participants. Completed in 17 January 2024.
| Lead sponsor | Ethicon, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 135 |
| Start date | 18 February 2019 |
| Primary completion | 17 January 2024 |
| Estimated completion | 17 January 2024 |
| Sites | 4 locations across China |
Ethicon, Inc. — full company profile →
18 and older, any sex, with Liver Tumor or Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Microwave Ablation With NEUWAVE | 107 |
Defined as the 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 Magnetic Resonance Imaging (MRI) performed up to 7 days post-ablation.
| Group | Value | 95% CI |
|---|---|---|
| Microwave Ablation With NEUWAVE | 112 |
Local Tumor Progression (LTP) was the appearance of tumor foci at the edge of the ablation zone, after at least one contrast-enhanced follow-up MRI scan had documented adequate ablation and an absence of viable tissue in the target tumor and surrounding ablation margin by using imaging.
| Group | Value | 95% CI |
|---|---|---|
| Microwave Ablation With NEUWAVE | 18 |
Measured from the time of the initial ablation procedure to the time of death or last follow-up, if death has not occurred
| Group | Value | 95% CI |
|---|---|---|
| Microwave Ablation With NEUWAVE | 13 |
The length of time from the original ablation procedure until any type of disease progression (local, regional, or distant) or until death.
| Group | Value | 95% CI |
|---|---|---|
| Microwave Ablation With NEUWAVE | 81 |
Time frame: 36 Months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Microwave Ablation With NE… |
|---|---|---|
| Hepatic cirrhosis | Hepatobiliary disorders | — |
| Jaundice cholestatic | Hepatobiliary disorders | — |
| Gastroenteritis | Infections and infestations | — |
| Cholecystitis | Hepatobiliary disorders | — |
| Hepatic function abnormal | Hepatobiliary disorders | — |
| Ascites | Gastrointestinal disorders | — |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | — |
| Biliary tract infection | Infections and infestations | — |
| Liver abscess | Infections and infestations | — |
| Postoperative wound infection | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Multiple organ dysfunction syndrome | General disorders | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — |
| Esophageal varices hemorrhage | Gastrointestinal disorders | — |
| Thermal burn | Injury, poisoning and procedural complications | — |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | — |
| Septic shock | Infections and infestations | — |
| Myocardial infarction | Cardiac disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Cerebral infarction | Nervous system disorders | — |
| Reaction | System | Microwave Ablation With NE… |
|---|---|---|
| Hepatic function abnormal | Hepatobiliary disorders | — |
| Procedural pain | Injury, poisoning and procedural complications | — |
| Pyrexia | General disorders | — |
| C-reactive protein increased | Investigations | — |
| Serum amyloid A protein increased | Investigations | — |
| Incision site pain | Injury, poisoning and procedural complications | — |
| Neutrophil count increased | Investigations | — |
| Leukocytosis | Blood and lymphatic system disorders | — |
| Abdominal pain upper | Gastrointestinal disorders | — |
| Hypertension | Vascular disorders | — |
| Hepatic cirrhosis | Hepatobiliary disorders | — |
Most-reported serious reactions: Hepatic cirrhosis, Jaundice cholestatic, Gastroenteritis, Cholecystitis, Hepatic function abnormal, Ascites, Gastrointestinal hemorrhage, Biliary tract infection.
Data from ClinicalTrials.gov NCT03783871 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing