Status:
TERMINATED
Ablation Confirmation Study
Lead Sponsor:
Ethicon, Inc.
Conditions:
Cancer of the Liver
Liver Cancer
Eligibility:
All Genders
22+ years
Phase:
NA
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 so...
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 under...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03753789
Start Date
November 5 2019
End Date
October 12 2022
Last Update
January 5 2024
Active Locations (6)
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1
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
2
UCLA
Los Angeles, California, United States, 90095
3
Olives View - UCLA Medical Center
Sylmar, California, United States, 91342
4
Mayo Clinic
Rochester, Minnesota, United States, 55902