Ablation Confirmation Study (NCT03753789) | Clinical Trial Compass
TerminatedNot Applicable
Ablation Confirmation Study
Stopped: Combined study endpoints with ongoing registry (NOLA/NEU\_2017\_04)
United States46 participantsStarted 2019-11-05
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Intent to use Ablation Confirmation software (any AC software version permitted) during the ablation procedure.
. Written Informed Consent to voluntarily participate in the study, follow CT scan schedule, and authorize the transfer of his/her data to the Sponsor
. Patients greater than or equal to 22 years of age
. Performance status 0-2 (Eastern Cooperative Oncology Group \[ECOG\]) classification
. Class A or B functional hepatic reserve based on the Child-Pugh score.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Lesions Where Probe Repositioning is Suggested
Timeframe: Day 0
2
Percentage of Lesions Where Re-ablation is Suggested
. 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
. Active bacterial infection or fungal infection on the day of the ablation.
. Patients with implantable pacemakers or other electronic implants.
. Platelet count less than 50,000/mm cubed.
. Patients with uncorrectable coagulopathy at the time of ablation.
. Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test, per site's SOC).
. Physical or psychological condition which would impair study participation.
. ASA (American Society of Anesthesiologists) score of great or equal to 4.