NCT03586050

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Hepatocellular Cancer
• Cancer, Hepatocellular

Interventions

Type	Name	Description
DEVICE	Microwave ablation	All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories

Timeline

• Start date: 2017-12-11
• Primary completion: 2020-05-21
• Completion: 2023-05-11
• First posted: 2018-07-13
• Last updated: 2024-07-24
• Results posted: 2021-08-23

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study