Status:
UNKNOWN
Registry Protocol- Melphalan Percutaneous Hepatic Perfusion for the Treatment of Unresectable Hepatic Malignancy
Lead Sponsor:
Delcath Systems Inc.
Conditions:
Hepatic Malignant Neoplasm Primary Non-Resectable
Eligibility:
All Genders
Brief Summary
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 Malig...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Have received CHEMOSAT treatment per IFU within the last 6-months or are planned to receive treatment with CHEMOSAT.
- Have provided written informed consent according to institutional and regulatory guidelines
Exclusion
Key Trial Info
Start Date :
January 14 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03266042
Start Date
January 14 2016
End Date
February 1 2020
Last Update
September 11 2018
Active Locations (2)
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1
Southampton University Hospitals and University of Southampton
Southampton, United Kingdom
2
Spire Southampton Hospital
Southampton, United Kingdom