Hepatic Malignant Neoplasm Primary Non-Resectable Clinical Trial
Official title:
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
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
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.
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