xml: <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/NCT05996809</url>
    </required_header>
    <id_info>
      <org_study_id>BXU571781</org_study_id>
      <nct_id>NCT05996809</nct_id>
    </id_info>
    <brief_title>PMCF Study for COSEAL® in Gynecologic Surgery</brief_title>
    <official_title>Post-Market Clinical Follow-up Study for COSEAL® in Gynecologic Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Baxter Healthcare Corporation</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Baxter Healthcare Corporation</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study is a single-arm, retrospective, chart review with a patient questionnaire intended&#xD;
        to supplement the patient chart, when necessary. The population will consist of patients who&#xD;
        underwent an index gynecologic surgery (performed at least 2 years prior to the start of the&#xD;
        study) during which COSEAL was used as an adjunct to good surgical technique to reduce the&#xD;
        incidence, severity, and extent of post-surgical adhesion formation. The purpose of the study&#xD;
        is to detect the incidence of adhesion-related morbidities as measured by the proportion of&#xD;
        adhesion-related readmissions, including reoperations in these patients.&#xD;
  &#xD;
        Patient charts will be reviewed to collect the data on readmissions related to adhesions, If&#xD;
        the patient chart has no record of adhesion related readmission within approximately 2 years&#xD;
        of the index surgery, then a patient questionnaire will be sent. A questionnaire may still be&#xD;
        sent if a patient chart has a record of adhesion related readmission within approximately 2&#xD;
        years of the index surgery and further clarification is needed. The questionnaire will&#xD;
        collect information regarding readmission or reoperation directly or possibly related to&#xD;
        adhesions following the index gynecologic surgical procedure at a hospital or outpatient&#xD;
        clinic other than that of the index surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of hospital readmissions directly or possibly related to adhesions following the use of COSEAL in gynecologic surgery, approximately 2 years from the date of index surgery.</measure>
      <time_frame>within 2 years of surgery</time_frame>
      <description>Patient charts will be reviewed to collect the data on readmissions related to adhesions, which are defined as:&#xD;
  Directly related to adhesions (adhesiolysis, non-operative readmissions for adhesions, and adhesiolysis operations on female reproductive tract);&#xD;
  Possibly related to adhesions (gynecologic operations, abdominal surgery, and nonoperative readmissions);&#xD;
  Open or laparoscopic reoperations that could potentially be complicated by present adhesions</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Adhesion</condition>
    <arm_group>
      <arm_group_label>Patients who underwent an index gynecologic surgery</arm_group_label>
      <description>The population will consist of patients who underwent an index gynecologic surgery (performed at least 2 years prior to the start of the study) during which COSEAL was used</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Coseal</intervention_name>
      <description>Adhesion reduction</description>
      <arm_group_label>Patients who underwent an index gynecologic surgery</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Data will be collected from adult female patient charts in whom COSEAL was used as an&#xD;
          adjunct to good surgical technique to reduce the incidence, severity, and extent of&#xD;
          post-surgical adhesion formation. Data will also be collected from the questionnaire&#xD;
          responses, when necessary&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adult female patients who, at the time of surgery, were ≥18 years of age and who have&#xD;
               undergone an index gynecologic surgery at least 2 years prior to the start of the&#xD;
               study.&#xD;
  &#xD;
            2. Patients in whom COSEAL was used for the reduction of post-surgical adhesion formation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1. Patients who had frank infection in the abdominopelvic cavity at the time of the surgery&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>gynecological surgery, adhesion related morbidities</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tissue Adhesions</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Upon approval of a legitimate research request.</ipd_time_frame>
      <ipd_access_criteria>Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.</ipd_access_criteria>
      <ipd_url>http://www.baxter.com/clinical-trial-transparency-and-data-sharing-policy</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996809
  org study id: BXU571781
  nct id: NCT05996809
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The study is a single-arm, retrospective, chart review with a patient questionnaire intended
        to supplement the patient chart, when necessary. The population will consist of patients who
        underwent an index gynecologic surgery (performed at least 2 years prior to the start of the
        study) during which COSEAL was used as an adjunct to good surgical technique to reduce the
        incidence, severity, and extent of post-surgical adhesion formation. The purpose of the study
        is to detect the incidence of adhesion-related morbidities as measured by the proportion of
        adhesion-related readmissions, including reoperations in these patients.
  
        Patient charts will be reviewed to collect the data on readmissions related to adhesions, If
        the patient chart has no record of adhesion related readmission within approximately 2 years
        of the index surgery, then a patient questionnaire will be sent. A questionnaire may still be
        sent if a patient chart has a record of adhesion related readmission within approximately 2
        years of the index surgery and further clarification is needed. The questionnaire will
        collect information regarding readmission or reoperation directly or possibly related to
        adhesions following the index gynecologic surgical procedure at a hospital or outpatient
        clinic other than that of the index surgery.
  observational model: Cohort
  time perspective: Retrospective
  measure: Incidence of hospital readmissions directly or possibly related to adhesions following the use of COSEAL in gynecologic surgery, approximately 2 years from the date of index surgery.
  time frame: within 2 years of surgery
  description: Patient charts will be reviewed to collect the data on readmissions related to adhesions, which are defined as:
  Directly related to adhesions (adhesiolysis, non-operative readmissions for adhesions, and adhesiolysis operations on female reproductive tract);
  Possibly related to adhesions (gynecologic operations, abdominal surgery, and nonoperative readmissions);
  Open or laparoscopic reoperations that could potentially be complicated by present adhesions
  arm group label: Patients who underwent an index gynecologic surgery
  description: The population will consist of patients who underwent an index gynecologic surgery (performed at least 2 years prior to the start of the study) during which COSEAL was used
  intervention type: Device
  intervention name: Coseal
  description: Adhesion reduction
  arm group label: Patients who underwent an index gynecologic surgery
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Tissue Adhesions
  sharing ipd: Yes
  ipd description: Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Upon approval of a legitimate research request.
  ipd access criteria: Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.
  ipd url: http://www.baxter.com/clinical-trial-transparency-and-data-sharing-policy