<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/NCT04496414</url>
  </required_header>
  <id_info>
    <org_study_id>C-BSEAL-001</org_study_id>
    <nct_id>NCT04496414</nct_id>
  </id_info>
  <brief_title>Bactiseal Catheter Safety Registry in China</brief_title>
  <official_title>A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Integra LifeSciences Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Integra LifeSciences Corporation</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>
      Research Purpose: This study aimed to continue to evaluate safety information from subjects&#xD;
      implanted with a catheter (trade name: Bactiseal) produced by Codman &amp; Shurtleff, Inc. of the&#xD;
      United States. Device safety would be assessed based on all the adverse events that occurred&#xD;
      within one year after the subjects implanted the catheter.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aimed to continue to evaluate safety information from subjects implanted with a&#xD;
      catheter (trade name: Bactiseal) produced by Codman &amp; Shurtleff, Inc. of the United States.&#xD;
      Device safety would be assessed based on all the adverse events that occurred within one year&#xD;
      after the subjects implanted the catheter.&#xD;
&#xD;
      This study was designed to be single arm, multi-center, and retrospective. A total of 50&#xD;
      patients would be retrospectively enrolled. Information would be collected on adverse events&#xD;
      of subjects enrolled within one year after the implantation of the Bactiseal Catheter from&#xD;
      August 07, 2018 to Novemver 30, 2020.&#xD;
&#xD;
      The following information would be collected from subjects' medical records or hospitals'&#xD;
      databases (if any):&#xD;
&#xD;
        1. General condition of the subjects&#xD;
&#xD;
        2. Intraoperative condition and catheter implantation&#xD;
&#xD;
        3. Information on the shunt product&#xD;
&#xD;
        4. Adverse events of subjects within one year after the operation and classification of the&#xD;
           adverse events&#xD;
&#xD;
        5. Relevant examinations in case of postoperative infection&#xD;
&#xD;
        6. Other adverse event-related information (except anticipated adverse events)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>50 Participants With Non-infection Within One Year</measure>
    <time_frame>1 year</time_frame>
    <description>50 Participants with Non-infection Within One Year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type and Incidence of Adverse Events of 50 Subjects Within One Year</measure>
    <time_frame>1 year</time_frame>
    <description>Type and incidence of adverse events of 50 subjects within one year after catheter implanted</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Hydrocephalus</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bactiseal Catheter</intervention_name>
    <description>Bactiseal Catheter manufactured by Codman &amp; Shurtleff, Inc. in the United States is a silicon catheter impregnated in rifampicin and clindamycin.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects had an indication suitable to use Bactiseal Catheter and have received a&#xD;
        hydrocephalus shunt at least one year ago.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The informed consent was exempted by the Ethics Committee of a research center. Either&#xD;
             a subject or his/her legal representative signed the informed consent form (ICF) prior&#xD;
             to enrollment.&#xD;
&#xD;
          -  A subject had an indication suitable to use Bactiseal Catheter.&#xD;
&#xD;
          -  A subject received a hydrocephalus shunt at least one year ago.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A subject didn't have an indication suitable to use the product.&#xD;
&#xD;
          -  A subject was known to be allergic to a component or ingredient of the product to be&#xD;
             implanted, including silicone tubing, rifampicin, and clindamycin.&#xD;
&#xD;
          -  According to the comprehensive judgment of an investigator, a subject had an infection&#xD;
             of the implant site when the shunt was implanted, such as ventriculitis, meningitis,&#xD;
             peritonitis, and local implant skin infection.&#xD;
&#xD;
          -  A subject was simultaneously implanted with another shunt system different from&#xD;
             Bactiseal Catheter.&#xD;
&#xD;
          -  A subject had a contraindication of the shunt operation.&#xD;
&#xD;
          -  A subject had uncorrected coagulopathy or any bleeding disorder.&#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_official>
    <last_name>Hua Tang, MD</last_name>
    <role>Study Director</role>
    <affiliation>Integra Life Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Children's Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100045</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <results_first_submitted>November 3, 2021</results_first_submitted>
  <results_first_submitted_qc>November 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 21, 2021</results_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hydrocephalus shunt</keyword>
  <keyword>infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocephalus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT04496414/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted in Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University, Beijing Children Hospital, Capital Medical University, Beijing Hospital. The first subject was enrolled in Sep 1, 2020, and last subject was enrolled in Nov 16, 2020.</recruitment_details>
      <pre_assignment_details>Screened 62 patients, 50 of them were enrolled, including 7 adult patients and 43 minors (subject age below 18). 12 patients were screening failures for not meeting inclusion/exclusion criteria and without post operation follow up.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Bactiseal Catheter Arm</title>
          <description>Hydrocephalus subjects implanted with a Bactiseal catheter for one year.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>50 enrolled subjects were included into PPS</population>
      <group_list>
        <group group_id="B1">
          <title>Bactiseal Catheter Arm</title>
          <description>Hydrocephalus subjects implanted with a Bactiseal catheter for one year.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>year</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.38" lower_limit="0.11" upper_limit="69.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>50 Participants With Non-infection Within One Year</title>
        <description>50 Participants with Non-infection Within One Year</description>
        <time_frame>1 year</time_frame>
        <population>50 participants implanted Bactiseal Catheter for 1 year</population>
        <group_list>
          <group group_id="O1">
            <title>Bactiseal Catheter Arm</title>
            <description>Hydrocephalus subjects implanted with a Bactiseal catheter for one year.</description>
          </group>
        </group_list>
        <measure>
          <title>50 Participants With Non-infection Within One Year</title>
          <description>50 Participants with Non-infection Within One Year</description>
          <population>50 participants implanted Bactiseal Catheter for 1 year</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Type and Incidence of Adverse Events of 50 Subjects Within One Year</title>
        <description>Type and incidence of adverse events of 50 subjects within one year after catheter implanted</description>
        <time_frame>1 year</time_frame>
        <posting_date>08/2043</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>within 1 year after investigated device implanted</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bactiseal Catheter Arm</title>
          <description>Hydrocephalus subjects implanted with a Bactiseal catheter for one year.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infectious pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>shunt device disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>shunt device occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>shunt blockage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Electrolyte disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>cerebral hemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>subdural hematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>intracranial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cerebrospinal fluid leakage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Demyelination</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Infantile spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Epilepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>diarrhea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>fever</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral hemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Subdural hematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Epilepsia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>respiratory infection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Hua Tang</name_or_title>
      <organization>Integra LifeSciences (Shanghai) Co., Ltd.</organization>
      <phone>0086 21 63179772</phone>
      <email>hua.tang@integralife.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04496414
org study id: C-BSEAL-001
nct id: NCT04496414
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Research Purpose: This study aimed to continue to evaluate safety information from subjects
      implanted with a catheter (trade name: Bactiseal) produced by Codman & Shurtleff, Inc. of the
      United States. Device safety would be assessed based on all the adverse events that occurred
      within one year after the subjects implanted the catheter.
This study aimed to continue to evaluate safety information from subjects implanted with a
      catheter (trade name: Bactiseal) produced by Codman & Shurtleff, Inc. of the United States.
      Device safety would be assessed based on all the adverse events that occurred within one year
      after the subjects implanted the catheter.

      This study was designed to be single arm, multi-center, and retrospective. A total of 50
      patients would be retrospectively enrolled. Information would be collected on adverse events
      of subjects enrolled within one year after the implantation of the Bactiseal Catheter from
      August 07, 2018 to Novemver 30, 2020.

      The following information would be collected from subjects' medical records or hospitals'
      databases (if any):

        1. General condition of the subjects

        2. Intraoperative condition and catheter implantation

        3. Information on the shunt product

        4. Adverse events of subjects within one year after the operation and classification of the
           adverse events

        5. Relevant examinations in case of postoperative infection

        6. Other adverse event-related information (except anticipated adverse events)
observational model: Cohort
time perspective: Other
measure: 50 Participants With Non-infection Within One Year
time frame: 1 year
description: 50 Participants with Non-infection Within One Year
measure: Type and Incidence of Adverse Events of 50 Subjects Within One Year
time frame: 1 year
description: Type and incidence of adverse events of 50 subjects within one year after catheter implanted
intervention type: Device
intervention name: Bactiseal Catheter
description: Bactiseal Catheter manufactured by Codman & Shurtleff, Inc. in the United States is a silicon catheter impregnated in rifampicin and clindamycin.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Hua Tang, MD
role: Study Director
affiliation: Integra Life Sciences
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Hydrocephalus
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 