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Ablation Confirmation Study

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase IV

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
22 Years
Maximum Age
N/A

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.
  • 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.
  • Use of hydrodissection.
  • Systemic chemotherapy or radiation therapy for the liver, within 30 days prior to the study ablation procedure.
  • INR greater than 1.8.
  • Patient has participated in an investigational clinical study within 30 days of the screening visit for this study.
  • Patient judged unsuitable for study participation by the performing physician for any other reason.

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Study Stats
Protocol No.
19-001411
Category
Oncology
Radiological Sciences
Contact
Arineh Aghakhani
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03753789
For detailed technical eligibility, visit ClinicalTrials.gov.