A Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Number of Participants Whose Ablation Resulted in Technical Success
研究概览
简要总结
This is a single arm, non-randomized, single center study to evaluate ablation, oncologic outcomes and safety in the treatment of hepatocellular carcinoma.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma which was previously treated with ablation or surgical resection only;
- •Scheduled for microwave ablation of the liver;
- •Performance status 0-1 (Eastern Cooperative Oncology Group classification);
- •Functional hepatic reserve based on the Child-Pugh score (Class A or B);
- •American Society of Anesthesiologists (ASA) score < 3;
- •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;
- •At least 19 years of age
排除标准
- •Active bacterial infection or fungal infection;
- •Systemic administration of steroids, including herbal supplements that contain steroids, within 30 days prior to the study procedure;
- •Chemotherapy or radiation therapy for hepatocellular carcinoma may not be performed for 30 days prior to the study procedure;
- •Subject with implantable pacemakers or other electronic implants;
- •Planned/ scheduled liver surgery.
- •Subject with a platelet count of less than 20,000/mm3;
- •Subject with an INR greater than 1.5;
- •Subject with renal failure on renal dialysis;
- •Scheduled concurrent procedure other than microwave ablation in the liver;
- •Pregnant or lactating;
- •Physical or psychological condition which would impair study participation;
- •Participation in any other clinical study concurrently or within the last 3 months;
- •The subject is judged unsuitable for study participation by the Investigator for any other reason;
- •Unable or unwilling to attend follow-up visits and examinations.
结局指标
主要结局
Number of Participants Whose Ablation Resulted in Technical Success
时间窗: Post ablation procedure (Day 0) up to 4 days
Number of participants whose ablation resulted in technical success were reported. Technical success was defined as complete tumor ablation with adequate or insufficient margin, based on contrast-enhanced Magnetic resonance imaging (MRI) and Computed scans immediately following the ablation procedure on Day 0 evaluated by the independent reviewer and principle investigator (PI) based on the response to the question "Confirm outcome of ablation".
次要结局
- Percentage of Participants With Adverse Events Within 36 Months Post Ablation(From time of first ablation (Day 0) up to 36 months post ablation)
- Progression Free Survival (PFS) Rate(At 36 months after the ablation procedure on Day 0)
- Change From Baseline in EORTC QLQ HCC 18 Scale Score(Baseline (Pre-Ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0))
- Health Economics: Complete Procedure Time(Day 0 (On day of ablation treatment))
- Health Economics: Median Number of Ablations(Day 0 (On the day of ablation treatment))
- Health Economics: Percentage of Participants With Single and Multi Probes Usage(Day 0 (On the day of ablation treatment))
- Number of Participants Whose Ablation Resulted in Primary Technique Efficacy(At 1 month after the ablation procedure on Day 0)
- Percentage of Participants With Secondary Efficacy(From time of first ablation (Day 0) up to 36 months)
- Percentage of Participants With Local Tumor Progression (LTP)(At 1, 3, 6, 9, 12, 18, 24, 30 and 36 months post ablation on Day 0)
- Percentage of Participants With Primary Efficacy(At 1, 3, 6, 9, 12, 18, 24, 30 and 36 months post ablation on Day 0)
- Overall Survival (OS) Rate(At 36 months after the ablation procedure on Day 0)
- Percentage of Participants With Adverse Events (AEs) Within 3 Months Post Ablation(From time of first ablation (Day 0) up to 3 months post ablation)
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Scale Score(Baseline (Pre-Ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0))
- Change From Baseline in Visual Analogue Scale (VAS) Pain Score(Baseline (Pre-Ablation), Day 0 (post ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0))
- Health Economics: Total Ablation Duration(Day 0 (On the day of ablation treatment))
- Health Economics: Length of Hospital Stay(Day 0 (On day of ablation treatment) up to 30 days (1-month post ablation visit))