Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP With the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Gather key safety data on the use of CHEMOSAT Kit (Gen 2 filter).
研究概览
简要总结
Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP with the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy
详细描述
Post Marketing study:
The CHEMOSAT kit containing Gen 2 filters has been used to treat patients since April 2012. This registry study is designed to collect safety, resource utilization and treatment outcomes in patients who receive this treatment with CHEMOSAT by healthcare professionals. The safety and efficacy data from patients treated with CHEMOSAT is important in updating the safety profile and for collection of treatment information. The resource utilization information is essential in planning treatment strategy for patients.
This registry does not follow any pre-determined protocol with respect to diagnosis, treatment or follow-up of the patient. The data collected will be gathered exclusively from current medical practice at participating institutions.
Delcath holds a list of authorized customer hospitals to whom it supplies the CHEMOSAT System. To date these hospitals have treated over 300 patients with cancers of the liver.
The decision to treat with CHEMOSAT is clearly separated from the decision to collect data in the registry. No specific procedures or tests are required in this protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Gather key safety data on the use of CHEMOSAT Kit (Gen 2 filter).
时间窗: Post-procedure (up to 30 days after CS-PHP)
Data to be collected at: Baseline, treatment and post treatment laboratory values and clinical measurements until time of discharge
次要结局
- Evaluation of resource utilization(From the first CHEMOSAT treatment through the last CHEMOSAT treatment [assessed up to 24 months])
- Percentage of treatment with CHEMOSAT each patient receives(From the first CHEMOSAT treatment through the last, [timeframe an average of 12-months if 6 cycles completed])
- Evaluate time to treatment failure(time from first CHEMOSAT treatment to the date of last CHEMOSAT treatment [assesed up to 24 months])
- Evaluation of Best Overall Response(from the date of first CHEMOSAT treatment through last CHEMOSAT treatment, or treatment discontinuation or death (whichever occurs first) [assessed up to 24 months])