Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-02 @ 1:08 PM
Study NCT ID:
NCT03586050
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2018-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea
Sponsor:
Ethicon, Inc.
Organization:
Study Overview
Official Title:
A Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: