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

Ethicon

Status: Completed

Conditions: Cancer, Hepatocellular; Carcinoma, Hepatocellular; Hepatocellular Cancer; Hepatocellular Carcinoma

Treatments: Device: Microwave ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03586050

NEU_2017_01

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Microwave Ablation

Experimental group

Description:

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

Treatment:

Device: Microwave ablation