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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586050
• Other study ID #: NEU_2017_01
• Status: Completed
• Phase: N/A
• Start date: December 11, 2017
• Est. completion date: May 11, 2023

Study information

• Verified date: June 2023
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 11, 2023
• Est. primary completion date: May 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer, Hepatocellular
• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Cancer
• Hepatocellular Carcinoma
• Liver Neoplasms

Intervention

Device:
• Microwave ablation
All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)