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

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

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

Study Overview

• Status: Completed
• Conditions: Carcinoma, Hepatocellular; Hepatocellular Carcinoma; Hepatocellular Cancer; Cancer, Hepatocellular
• Intervention / Treatment: Device: Microwave ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma which was previously treated with ablation or surgical resection only;
3. Scheduled for microwave ablation of the liver;
4. Performance status 0-1 (Eastern Cooperative Oncology Group classification);
5. Functional hepatic reserve based on the Child-Pugh score (Class A or B);
6. American Society of Anesthesiologists (ASA) score < 3;
7. 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;
8. At least 19 years of age

Exclusion Criteria:

1. Active bacterial infection or fungal infection;
2. Systemic administration of steroids, including herbal supplements that contain steroids, within 30 days prior to the study procedure;
3. Chemotherapy or radiation therapy for hepatocellular carcinoma may not be performed for 30 days prior to the study procedure;
4. Subject with implantable pacemakers or other electronic implants;
5. Planned/ scheduled liver surgery.
6. Subject with a platelet count of less than 20,000/mm3;
7. Subject with an INR greater than 1.5;
8. Subject with renal failure on renal dialysis;
9. Scheduled concurrent procedure other than microwave ablation in the liver;
10. Pregnant or lactating;
11. Physical or psychological condition which would impair study participation;
12. Participation in any other clinical study concurrently or within the last 3 months;
13. The subject is judged unsuitable for study participation by the Investigator for any other reason;
14. Unable or unwilling to attend follow-up visits and examinations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microwave Ablation; All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories	Device: Microwave ablation; All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories

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)

Collaborators and Investigators

• Sponsor: Ethicon, Inc.
• Investigators: Principal Investigator: Hyunchul Rhim, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Actual): May 21, 2020
• Study Completion (Actual): May 11, 2023

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; liver cancer; cancer; liver
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: NEU_2017_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes