Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea

Study Overview
=================
Brief Summary
-----------------
This is a single arm, non-randomized, single center study to evaluate ablation, oncologic outcomes and safety in the treatment of hepatocellular carcinoma.

Detailed Description
-----------------
This prospective, single-arm single center study will provide clinical data for the Neuwave Medical Microwave Ablation System and accessories. Individuals who undergo microwave ablation of liver tumors who meet study entry criteria, will be enrolled. The enrollment for the study will continue until 30 eligible subjects complete the 3-month visit after ablation for the primary effectiveness and safety analysis. The subjects will be followed for approximately up to 36 months after the ablation procedure for safety, oncologic and ablation outcomes.

Official Title
-----------------
A Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea

Conditions
-----------------
Carcinoma, Hepatocellular, Hepatocellular Carcinoma, Hepatocellular Cancer, Cancer, Hepatocellular

Intervention / Treatment
-----------------
* Device: Microwave ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed hepatocellular carcinoma, tumor size of more than 2 cm and up to 5cm, single location, Barcelona Clinic Liver Cancer (BCLC) Stage A based on imaging and biopsy confirmation Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma which was previously treated with ablation or surgical resection only; Scheduled for microwave ablation of the liver; Performance status 0-1 (Eastern Cooperative Oncology Group classification); Functional hepatic reserve based on the Child-Pugh score (Class A or B); American Society of Anesthesiologists (ASA) score < 3; Given voluntary, written informed consent to participate in this study and has authorized the transfer of his/her information to the Sponsor, and willing to comply with study-related evaluation and treatment schedule; At least 19 years of age Exclusion Criteria: Active bacterial infection or fungal infection; Systemic administration of steroids, including herbal supplements that contain steroids, within 30 days prior to the study procedure; Chemotherapy or radiation therapy for hepatocellular carcinoma may not be performed for 30 days prior to the study procedure; Subject with implantable pacemakers or other electronic implants; Planned/ scheduled liver surgery. Subject with a platelet count of less than 20,000/mm3; Subject with an INR greater than 1.5; Subject with renal failure on renal dialysis; Scheduled concurrent procedure other than microwave ablation in the liver; Pregnant or lactating; Physical or psychological condition which would impair study participation; Participation in any other clinical study concurrently or within the last 3 months; The subject is judged unsuitable for study participation by the Investigator for any other reason; Unable or unwilling to attend follow-up visits and examinations.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microwave Ablation<br>All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories | Device: Microwave ablation<br>* All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Whose Ablation Resulted in Technical Success | complete tumor ablation with adequate or insufficient margin, based on contrast-enhanced MRI and CT scans | immediately following (or up to 4 days after) the ablation procedure (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Whose Ablation Resulted in Technique Efficacy | complete tumor ablation with adequate or insufficient ablation margin based on contrast-enhanced MRI and CT scans; scans may be done up to 14 days prior to the 1 month visit | 1 month after the ablation procedure (Day 0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular Carcinoma; liver cancer; cancer; liver