Registry Protocol- Melphalan Percutaneous Hepatic Perfusion for the Treatment of Unresectable Hepatic Malignancy
NCT ID: NCT03266042
Last Updated: 2018-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2016-01-14
2020-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
OTHER
Eligibility Criteria
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Inclusion Criteria
2. Have provided written informed consent according to institutional and regulatory guidelines
ALL
No
Sponsors
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Delcath Systems Inc.
INDUSTRY
Responsible Party
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Locations
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Southampton University Hospitals and University of Southampton
Southampton, , United Kingdom
Spire Southampton Hospital
Southampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Ioannis Karydis, Dr.
Role: primary
Sanjay Gupta, Dr.
Role: primary
Other Identifiers
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PHP-M-REG01
Identifier Type: -
Identifier Source: org_study_id
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