Trial Outcomes & Findings for NeuWave Microwave Ablation HCC China Study (NCT NCT03783871)

Last Updated: 2025-04-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

135 participants

Primary outcome timeframe

Day 23 to Day 37

Results posted on

2025-04-25

Participant Flow

143 participants signed the informed consent, 8 of whom were later screen failures as they did not meet all inclusion/exclusion criteria. These 8 participants were not treated with the NEUWAVE microwave ablation device.

135 participants met all inclusion/exclusion criteria. All participants were treated with the NEUWAVE microwave ablation device. The first 3 participants at each of the 4 clinical sites (12 participants total) were part of the 'run-in' phase and the remaining 123 participants were part of the 'full-analysis set', used for statistical analysis.

Participant milestones

Participant milestones
Measure	Microwave Ablation With NEUWAVE Each participant underwent microwave ablation with NEUWAVE for the treatment of a single HCC tumor up to 5 cm or up to three HCC tumors, no more than 3 cm per tumor, in accordance with the study protocol.
Overall Study STARTED	135
Overall Study COMPLETED	105
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Microwave Ablation With NEUWAVE Each participant underwent microwave ablation with NEUWAVE for the treatment of a single HCC tumor up to 5 cm or up to three HCC tumors, no more than 3 cm per tumor, in accordance with the study protocol.
Overall Study Withdrawal by Subject	15
Overall Study Death	13
Overall Study Lost to Follow-up	2

Baseline Characteristics

NeuWave Microwave Ablation HCC China Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Microwave Ablation With NEUWAVE n=123 Participants Each participant underwent microwave ablation with NEUWAVE for the treatment of a single HCC tumor up to 5 cm or up to three HCC tumors, no more than 3 cm per tumor, in accordance with the study protocol.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Age, Continuous	58.6 Years STANDARD_DEVIATION 10.68 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	123 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	123 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 23 to Day 37

Population: Each participant underwent microwave ablation with NEUWAVE for the treatment of a single HCC tumor up to 5 cm or up to three HCC tumors, no more than 3 cm per tumor. This excludes the run-in participants.

Outcome measures

Outcome measures
Measure	Microwave Ablation With NEUWAVE n=115 Participants Each participant underwent microwave ablation with NEUWAVE for the treatment of a single HCC tumor up to 5 cm or up to three HCC tumors, no more than 3 cm per tumor, in accordance with the study protocol.
Technical Efficacy	107 Participants

SECONDARY outcome

Timeframe: Day 0 to Day 7

Population: Each participant underwent microwave ablation with NEUWAVE for the treatment of a single HCC tumor up to 5 cm or up to three HCC tumors, no more than 3 cm per tumor, in accordance with the study protocol. This excludes the run-in participants.

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.

Outcome measures

Outcome measures
Measure	Microwave Ablation With NEUWAVE n=119 Participants Each participant underwent microwave ablation with NEUWAVE for the treatment of a single HCC tumor up to 5 cm or up to three HCC tumors, no more than 3 cm per tumor, in accordance with the study protocol.
Technical Success	112 Participants

SECONDARY outcome

Timeframe: 1 Month to 36 Months

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.

Outcome measures

Outcome measures
Measure	Microwave Ablation With NEUWAVE n=123 Participants Each participant underwent microwave ablation with NEUWAVE for the treatment of a single HCC tumor up to 5 cm or up to three HCC tumors, no more than 3 cm per tumor, in accordance with the study protocol.
Local Tumor Progression	18 Participants

SECONDARY outcome

Timeframe: 36 months

Measured from the time of the initial ablation procedure to the time of death or last follow-up, if death has not occurred

Outcome measures

Outcome measures
Measure	Microwave Ablation With NEUWAVE n=135 Participants Each participant underwent microwave ablation with NEUWAVE for the treatment of a single HCC tumor up to 5 cm or up to three HCC tumors, no more than 3 cm per tumor, in accordance with the study protocol.
Overall Survival	13 Participants

SECONDARY outcome

Timeframe: 36 months

The length of time from the original ablation procedure until any type of disease progression (local, regional, or distant) or until death.

Outcome measures

Outcome measures
Measure	Microwave Ablation With NEUWAVE n=123 Participants Each participant underwent microwave ablation with NEUWAVE for the treatment of a single HCC tumor up to 5 cm or up to three HCC tumors, no more than 3 cm per tumor, in accordance with the study protocol.
Progression-Free Survival	81 Participants

Adverse Events

Microwave Ablation With NEUWAVE

Serious events: 42 serious events

Other events: 115 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Microwave Ablation With NEUWAVE n=135 participants at risk Each participant underwent microwave ablation with NEUWAVE for the treatment of a single HCC tumor up to 5 cm or up to three HCC tumors, no more than 3 cm per tumor, in accordance with the study protocol. Includes the run-in participants.
Infections and infestations Gastroenteritis	2.2% 3/135 • Number of events 3 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Hepatobiliary disorders Hepatic cirrhosis	5.2% 7/135 • Number of events 7 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Hepatobiliary disorders Jaundice cholestatic	3.0% 4/135 • Number of events 5 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Hepatobiliary disorders Cholecystitis	1.5% 2/135 • Number of events 2 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Hepatobiliary disorders Hepatic function abnormal	1.5% 2/135 • Number of events 2 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Gastrointestinal disorders Ascites	1.5% 2/135 • Number of events 3 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Gastrointestinal disorders Gastrointestinal hemorrhage	1.5% 2/135 • Number of events 2 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Infections and infestations Biliary tract infection	1.5% 2/135 • Number of events 2 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Infections and infestations Liver abscess	1.5% 2/135 • Number of events 2 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Infections and infestations Postoperative wound infection	1.5% 2/135 • Number of events 2 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Infections and infestations Sepsis	1.5% 2/135 • Number of events 2 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
General disorders Multiple organ dysfunction syndrome	1.5% 2/135 • Number of events 2 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Injury, poisoning and procedural complications Thermal burn	0.74% 1/135 • Number of events 1 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.74% 1/135 • Number of events 1 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Infections and infestations Septic shock	0.74% 1/135 • Number of events 1 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.5% 2/135 • Number of events 3 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Gastrointestinal disorders Esophageal varices hemorrhage	1.5% 2/135 • Number of events 2 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Cardiac disorders Myocardial infarction	0.74% 1/135 • Number of events 1 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.74% 1/135 • Number of events 1 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Nervous system disorders Cerebral infarction	0.74% 1/135 • Number of events 1 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).

Other adverse events

Other adverse events
Measure	Microwave Ablation With NEUWAVE n=135 participants at risk Each participant underwent microwave ablation with NEUWAVE for the treatment of a single HCC tumor up to 5 cm or up to three HCC tumors, no more than 3 cm per tumor, in accordance with the study protocol. Includes the run-in participants.
Hepatobiliary disorders Hepatic function abnormal	48.9% 66/135 • Number of events 67 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Injury, poisoning and procedural complications Procedural pain	31.9% 43/135 • Number of events 43 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Investigations C-reactive protein increased	10.4% 14/135 • Number of events 14 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Investigations Serum amyloid A protein increased	10.4% 14/135 • Number of events 14 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
General disorders Pyrexia	21.5% 29/135 • Number of events 29 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Hepatobiliary disorders Hepatic cirrhosis	5.2% 7/135 • Number of events 7 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Injury, poisoning and procedural complications Incision site pain	9.6% 13/135 • Number of events 13 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Gastrointestinal disorders Abdominal pain upper	5.9% 8/135 • Number of events 9 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Investigations Neutrophil count increased	8.9% 12/135 • Number of events 12 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Blood and lymphatic system disorders Leukocytosis	7.4% 10/135 • Number of events 10 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).
Vascular disorders Hypertension	5.9% 8/135 • Number of events 8 • 36 Months Adverse Events (AEs) were defined as any undesirable clinical occurrence in a participant, whether attributable to the study device/procedure or not. AEs were captured for the first 30 days after the ablation procedure. After 30 days, only Serious Adverse Events (SAEs) were captured throughout the duration of the study (36 months).

Additional Information

Erin Meyers

Ethicon

Phone: 937-681-0322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place