<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03266042</url>
  </required_header>
  <id_info>
    <org_study_id>PHP-M-REG01</org_study_id>
    <nct_id>NCT03266042</nct_id>
  </id_info>
  <brief_title>Registry Protocol- Melphalan Percutaneous Hepatic Perfusion for the Treatment of Unresectable Hepatic Malignancy</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Delcath Systems Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Delcath Systems Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have&#xD;
      Received Melphalan PHP with the Delcath Hepatic Delivery System for the Treatment of&#xD;
      Unresectable Hepatic Malignancy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post Marketing study:&#xD;
&#xD;
      The CHEMOSAT kit containing Gen 2 filters has been used to treat patients since April 2012.&#xD;
      This registry study is designed to collect safety, resource utilization and treatment&#xD;
      outcomes in patients who receive this treatment with CHEMOSAT by healthcare professionals.&#xD;
      The safety and efficacy data from patients treated with CHEMOSAT is important in updating the&#xD;
      safety profile and for collection of treatment information. The resource utilization&#xD;
      information is essential in planning treatment strategy for patients.&#xD;
&#xD;
      This registry does not follow any pre-determined protocol with respect to diagnosis,&#xD;
      treatment or follow-up of the patient. The data collected will be gathered exclusively from&#xD;
      current medical practice at participating institutions.&#xD;
&#xD;
      Delcath holds a list of authorized customer hospitals to whom it supplies the CHEMOSAT&#xD;
      System. To date these hospitals have treated over 300 patients with cancers of the liver.&#xD;
&#xD;
      The decision to treat with CHEMOSAT is clearly separated from the decision to collect data in&#xD;
      the registry. No specific procedures or tests are required in this protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 14, 2016</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Gather key safety data on the use of CHEMOSAT Kit (Gen 2 filter).</measure>
    <time_frame>Post-procedure (up to 30 days after CS-PHP)</time_frame>
    <description>Data to be collected at: Baseline, treatment and post treatment laboratory values and clinical measurements until time of discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of treatment with CHEMOSAT each patient receives</measure>
    <time_frame>From the first CHEMOSAT treatment through the last, [timeframe an average of 12-months if 6 cycles completed]</time_frame>
    <description>The percentage of treatments with CHEMOSAT each patient receives based on primary tumor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Best Overall Response</measure>
    <time_frame>from the date of first CHEMOSAT treatment through last CHEMOSAT treatment, or treatment discontinuation or death (whichever occurs first) [assessed up to 24 months]</time_frame>
    <description>Evaluation of patient best overall response (partial response or complete response, when applicable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of resource utilization</measure>
    <time_frame>From the first CHEMOSAT treatment through the last CHEMOSAT treatment [assessed up to 24 months]</time_frame>
    <description>Percentage of days spent in ICU, step-down area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate time to treatment failure</measure>
    <time_frame>time from first CHEMOSAT treatment to the date of last CHEMOSAT treatment [assesed up to 24 months]</time_frame>
    <description>Time of first CHEMOSAT treatment to time of treatment failure</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Hepatic Malignant Neoplasm Primary Non-Resectable</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have&#xD;
        Received or will receive treatment with CHEMOSAT for the Treatment of Unresectable Hepatic&#xD;
        Malignancy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        1. Have received CHEMOSAT treatment per IFU within the last 6-months or are planned to&#xD;
             receive treatment with CHEMOSAT.&#xD;
&#xD;
          2. Have provided written informed consent according to institutional and regulatory&#xD;
             guidelines&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Leslie Callahan, BSN, MS</last_name>
    <phone>212-489-2100</phone>
    <phone_ext>247</phone_ext>
    <email>lcallahan@delcath.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nathalie Riebel, MBA</last_name>
    <phone>212-489-2100</phone>
    <phone_ext>238</phone_ext>
    <email>nriebel@delcath.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Southampton University Hospitals and University of Southampton</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ioannis Karydis, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Spire Southampton Hospital</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sanjay Gupta, Dr.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
  </removed_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>September 7, 2018</last_update_submitted>
  <last_update_submitted_qc>September 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03266042
org study id: PHP-M-REG01
nct id: NCT03266042
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Other
time perspective: Other
measure: Gather key safety data on the use of CHEMOSAT Kit (Gen 2 filter).
time frame: Post-procedure (up to 30 days after CS-PHP)
description: Data to be collected at: Baseline, treatment and post treatment laboratory values and clinical measurements until time of discharge
measure: Percentage of treatment with CHEMOSAT each patient receives
time frame: From the first CHEMOSAT treatment through the last, [timeframe an average of 12-months if 6 cycles completed]
description: The percentage of treatments with CHEMOSAT each patient receives based on primary tumor
measure: Evaluation of Best Overall Response
time frame: from the date of first CHEMOSAT treatment through last CHEMOSAT treatment, or treatment discontinuation or death (whichever occurs first) [assessed up to 24 months]
description: Evaluation of patient best overall response (partial response or complete response, when applicable)
measure: Evaluation of resource utilization
time frame: From the first CHEMOSAT treatment through the last CHEMOSAT treatment [assessed up to 24 months]
description: Percentage of days spent in ICU, step-down area
measure: Evaluate time to treatment failure
time frame: time from first CHEMOSAT treatment to the date of last CHEMOSAT treatment [assesed up to 24 months]
description: Time of first CHEMOSAT treatment to time of treatment failure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Leslie Callahan, BSN, MS
phone: 212-489-2100
phone ext: 247
email: lcallahan@delcath.com
last name: Nathalie Riebel, MBA
phone: 212-489-2100
phone ext: 238
email: nriebel@delcath.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United Kingdom
country: Germany
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: Undecided