Cancer of the Liver, Liver Cancer, Neoplasms, Liver
Conditions
Brief summary
Prospective, single-arm, multicenter study that will generate clinical data using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion.
Detailed description
Prospective, single-arm, multicenter study that will generate clinical data on 100 adult patients using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion. AC software is a computed tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE Microwave Ablation System. AC imports images from CT scanners for display and processing during ablation procedures to assist physicians in identifying ablation targets, assessing optimal ablation probe placement, and confirming the adequacy of the ablation margin. All ablations will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.
Interventions
DEVICEMicrowave Ablation
NEUWAVE microwave ablation of soft tissue liver lesions will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.
Sponsors
Ethicon, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A patient with at least one soft-tissue liver lesion less than or equal to 5cm undergoing microwave ablation using the NEUWAVE Microwave Ablation System. Note: a patient cannot have more than 3 lesions ablated during the procedure. 2. Intent to use Ablation Confirmation software (any AC software version permitted) during the ablation procedure. 3. Written Informed Consent to voluntarily participate in the study, follow CT scan schedule, and authorize the transfer of his/her data to the Sponsor 4. Patients greater than or equal to 22 years of age 5. Performance status 0-2 (Eastern Cooperative Oncology Group \[ECOG\]) classification 6. Class A or B functional hepatic reserve based on the Child-Pugh score. 7. Lesion must be visualized by non-contrast enhanced CT scan or the patient must tolerate contrast and meet institutional guidelines for contrast use based on glomerular filtration rate (GFR).
Exclusion criteria
1. Active bacterial infection or fungal infection on the day of the ablation. 2. Patients with implantable pacemakers or other electronic implants. 3. Platelet count less than 50,000/mm cubed. 4. Patients with uncorrectable coagulopathy at the time of ablation. 5. Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test, per site's SOC). 6. Physical or psychological condition which would impair study participation. 7. ASA (American Society of Anesthesiologists) score of great or equal to 4. 8. Use of hydrodissection. 9. Systemic chemotherapy or radiation therapy for the liver, within 30 days prior to the study ablation procedure. 10. INR greater than 1.8. 11. Patient has participated in an investigational clinical study within 30 days of the screening visit for this study. 12. Patient judged unsuitable for study participation by the performing physician for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Lesions Where Probe Repositioning is Suggested | Day 0 |
| Percentage of Lesions Where Re-ablation is Suggested | Day 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Day 0 | Ablation of the target lesion(s) according to the protocol and covered completely with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin) |
| Technique Efficacy | 6 weeks | Ablation of the target lesion(s) according to the protocol and covered completely with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin) as assessed by imaging at 6 weeks |
| Hospital Resource Utilization | 6 weeks | How many days patients remain in the hospital after the ablation procedure |
Countries
United States
Participant flow
Recruitment details
46 participants signed the informed consent, 7 of whom were later screen failures as they did not meet all inclusion/exclusion criteria. These 7 participants were not treated with the NEUWAVE microwave ablation device.
Pre-assignment details
39 participants met all inclusion/exclusion criteria. All participants were treated with the NEUWAVE microwave ablation device. However, 1 participant did not have the Ablation Confirmation software used in conjunction with the NEUWAVE microwave ablation device, as planned, and was therefore excluded in the full analysis set, defined as the 'Started' population.
Participants by arm
| Arm | Count |
|---|---|
| Microwave Ablation With Ablation Confirmation Software Each participant underwent NEUWAVE microwave ablation using Ablation Confirmation software of at least one soft-tissue liver lesion in accordance with the study site's standard-of-care. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Microwave Ablation With Ablation Confirmation Software |
|---|---|
| Age, Continuous | 61.6 Years STANDARD_DEVIATION 9.596 |
| BMI | 30.8 Kg/m^2 STANDARD_DEVIATION 5.469 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Not Reported | 6 Participants |
| Race/Ethnicity, Customized White/Caucasian | 29 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 26 Participants |
| Smoking Status Current Smoker | 2 Participants |
| Smoking Status Former Smoker | 15 Participants |
| Smoking Status Non-Smoker | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 4 / 38 |
| serious Total, serious adverse events | 4 / 38 |
Outcome results
Primary
Percentage of Lesions Where Probe Repositioning is Suggested
Time frame: Day 0
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Microwave Ablation | Percentage of Lesions Where Probe Repositioning is Suggested | Actions taken due to AC software indicating probe placement not satisfactory | 16 Lesions |
| Microwave Ablation | Percentage of Lesions Where Probe Repositioning is Suggested | No actions taken despite AC software indicating probe placement not satisfactory | 2 Lesions |
| Microwave Ablation | Percentage of Lesions Where Probe Repositioning is Suggested | No actions taken due to AC software indicating satisfactory probe placement | 29 Lesions |
Primary
Percentage of Lesions Where Re-ablation is Suggested
Time frame: Day 0
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Microwave Ablation | Percentage of Lesions Where Re-ablation is Suggested | Actions taken due to AC software indicating ablation margin not complete | 2 Lesions |
| Microwave Ablation | Percentage of Lesions Where Re-ablation is Suggested | No actions taken despite AC software indicating ablation margin not complete | 8 Lesions |
| Microwave Ablation | Percentage of Lesions Where Re-ablation is Suggested | No actions taken due to AC software indicating satisfactory margins | 37 Lesions |
Secondary
Hospital Resource Utilization
How many days patients remain in the hospital after the ablation procedure
Time frame: 6 weeks
Population: Only 27 patients had this data available. When not collected, this was noted as a protocol deviation.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Microwave Ablation | Hospital Resource Utilization | Discharged the same day as the ablation procedure | 16 Participants |
| Microwave Ablation | Hospital Resource Utilization | Discharged after one night following the ablation procedure | 10 Participants |
| Microwave Ablation | Hospital Resource Utilization | Discharged two or more nights following the ablation procedure | 1 Participants |
Secondary
Technical Success
Ablation of the target lesion(s) according to the protocol and covered completely with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin)
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Microwave Ablation | Technical Success | 46 Lesions |
Secondary
Technique Efficacy
Ablation of the target lesion(s) according to the protocol and covered completely with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin) as assessed by imaging at 6 weeks
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Microwave Ablation | Technique Efficacy | 44 Lesions |