Registry Protocol- Melphalan Percutaneous Hepatic Perfusion for the Treatment of Unresectable Hepatic Malignancy

Last updated: September 7, 2018
Sponsor: Delcath Systems Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Cancer

Digestive System Neoplasms

Neoplasms

Treatment

N/A

Clinical Study ID

NCT03266042
PHP-M-REG01
  • All Genders

Study 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 Malignancy

Eligibility Criteria

Inclusion

  1. Have received CHEMOSAT treatment per IFU within the last 6-months or are planned to receive treatment with CHEMOSAT.

  2. Have provided written informed consent according to institutional and regulatory guidelines

Study Design

Total Participants: 200
Study Start date:
January 14, 2016
Estimated Completion Date:
February 29, 2020

Study 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 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.

Connect with a study center

  • Universitätsklinikum Frankfurt - Goethe-Universität

    Frankfurt,
    Germany

    Site Not Available

  • Aintree University Hospital

    Liverpool,
    United Kingdom

    Site Not Available

  • Southampton University Hospitals and University of Southampton

    Southampton,
    United Kingdom

    Active - Recruiting

  • Spire Southampton Hospital

    Southampton,
    United Kingdom

    Active - Recruiting

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