Trial Outcomes & Findings for Ablation Confirmation Study (NCT NCT03753789)

NCT ID: NCT03753789

Last Updated: 2024-01-05

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: Day 0
• Results posted on: 2024-01-05

Participant Flow

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.

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.

Unit of analysis: Lesions

Participant milestones

Measure	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.
Overall Study STARTED	38 47
Overall Study COMPLETED	36 44
Overall Study NOT COMPLETED	2 3

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Ablation Confirmation Study

Baseline characteristics by cohort

Measure	Microwave Ablation With Ablation Confirmation Software n=38 Participants 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.
Age, Continuous	61.6 Years STANDARD_DEVIATION 9.596 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	29 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	6 Participants n=5 Participants
BMI	30.8 Kg/m^2 STANDARD_DEVIATION 5.469 • n=5 Participants
Smoking Status Current Smoker	2 Participants n=5 Participants
Smoking Status Former Smoker	15 Participants n=5 Participants
Smoking Status Non-Smoker	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0

Outcome measures

Measure	Microwave Ablation n=47 Lesions Each participant underwent microwave ablation using NEUWAVE and the Ablation Confirmation software for at least one soft-tissue liver lesion in accordance with the study site's standard-of-care
Percentage of Lesions Where Probe Repositioning is Suggested Actions taken due to AC software indicating probe placement not satisfactory	16 Lesions
Percentage of Lesions Where Probe Repositioning is Suggested No actions taken despite AC software indicating probe placement not satisfactory	2 Lesions
Percentage of Lesions Where Probe Repositioning is Suggested No actions taken due to AC software indicating satisfactory probe placement	29 Lesions

PRIMARY outcome

Timeframe: Day 0

Outcome measures

Measure	Microwave Ablation n=47 Lesions Each participant underwent microwave ablation using NEUWAVE and the Ablation Confirmation software for at least one soft-tissue liver lesion in accordance with the study site's standard-of-care
Percentage of Lesions Where Re-ablation is Suggested Actions taken due to AC software indicating ablation margin not complete	2 Lesions
Percentage of Lesions Where Re-ablation is Suggested No actions taken despite AC software indicating ablation margin not complete	8 Lesions
Percentage of Lesions Where Re-ablation is Suggested No actions taken due to AC software indicating satisfactory margins	37 Lesions

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Microwave Ablation n=47 Lesions Each participant underwent microwave ablation using NEUWAVE and the Ablation Confirmation software for at least one soft-tissue liver lesion in accordance with the study site's standard-of-care
Technical Success	46 Lesions

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Microwave Ablation n=44 Lesions Each participant underwent microwave ablation using NEUWAVE and the Ablation Confirmation software for at least one soft-tissue liver lesion in accordance with the study site's standard-of-care
Technique Efficacy	44 Lesions

SECONDARY outcome

Timeframe: 6 weeks

Population: Only 27 patients had this data available. When not collected, this was noted as a protocol deviation.

How many days patients remain in the hospital after the ablation procedure

Outcome measures

Measure	Microwave Ablation n=27 Participants Each participant underwent microwave ablation using NEUWAVE and the Ablation Confirmation software for at least one soft-tissue liver lesion in accordance with the study site's standard-of-care
Hospital Resource Utilization Discharged the same day as the ablation procedure	16 Participants
Hospital Resource Utilization Discharged after one night following the ablation procedure	10 Participants
Hospital Resource Utilization Discharged two or more nights following the ablation procedure	1 Participants

Adverse Events

Microwave Ablation With Ablation Confirmation Software

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Microwave Ablation With Ablation Confirmation Software n=38 participants at risk 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.
Gastrointestinal disorders Abdominal pain	7.9% 3/38 • Number of events 3 • 6 weeks Per the study protocol, only events that the site investigator determined to be device-related and/or procedure-related were captured within the study database as this was a post-market study. These events were evaluated from the time of first probe puncture (Day 0) through study completion (6 weeks).
Gastrointestinal disorders Perihepatic fluid collection	2.6% 1/38 • Number of events 1 • 6 weeks Per the study protocol, only events that the site investigator determined to be device-related and/or procedure-related were captured within the study database as this was a post-market study. These events were evaluated from the time of first probe puncture (Day 0) through study completion (6 weeks).

Other adverse events

Measure	Microwave Ablation With Ablation Confirmation Software n=38 participants at risk 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.
Gastrointestinal disorders Abdominal pain	5.3% 2/38 • Number of events 2 • 6 weeks Per the study protocol, only events that the site investigator determined to be device-related and/or procedure-related were captured within the study database as this was a post-market study. These events were evaluated from the time of first probe puncture (Day 0) through study completion (6 weeks).
Injury, poisoning and procedural complications Procedural pain	5.3% 2/38 • Number of events 2 • 6 weeks Per the study protocol, only events that the site investigator determined to be device-related and/or procedure-related were captured within the study database as this was a post-market study. These events were evaluated from the time of first probe puncture (Day 0) through study completion (6 weeks).

Additional Information

Erin Meyers

Ethicon

Phone: 937-681-0322

Email: eprifog1@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60