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 range22 Years
SexALL
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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.
✓. 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.
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