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/NCT06022510</url>
    </required_header>
    <id_info>
      <org_study_id>H-53644</org_study_id>
      <nct_id>NCT06022510</nct_id>
    </id_info>
    <brief_title>Safety and Efficacy of Fetoscopes Used in Fetoscopic Selective Laser Photocoagulation</brief_title>
    <official_title>Safety and Efficacy of Fetoscopes Used in Fetoscopic Selective Laser Photocoagulation for Complicated Monochorionic-Diamniotic Pregnancies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Michael A Belfort</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Baylor College of Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Baylor College of Medicine</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the safety and efficacy of the investigational&#xD;
        fetoscopes used in patients undergoing fetoscopic selective laser photocoagulation for&#xD;
        complicated monochorionic-diamniotic pregnancies.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All patients who choose to undergo fetoscopic selective laser photocoagulation (S-PLC) at&#xD;
        Texas Children's Fetal Center will be offered participation in this research study by study&#xD;
        investigators. Description of study rationale and design and a focused interview by the study&#xD;
        coordinator to afford potential participants a formal opportunity to examine what they have&#xD;
        learned about the research study in the course of their evaluation and discuss how they feel&#xD;
        about enrolling in the research study. Once the patient is deemed eligible the informed&#xD;
        consent process will be reviewed. If patients elect to participate in the study, informed&#xD;
        consent will be obtained, and patients provided a copy of the signed consent.&#xD;
  &#xD;
        Fetoscopic Procedure: Selective laser photocoagulation (S-PLC) is standard of care for the&#xD;
        treatment of complicated monochorionic twin pregnancies and will be performed with the same&#xD;
        technique in this study as it is with the use of the currently approved fetoscopes. In the&#xD;
        majority of cases, in utero access has been achieved using a small percutaneous incision&#xD;
        under ultrasound guidance with the instruments inserted through the maternal abdomen, uterine&#xD;
        wall and into the recipient fetus' gestational sac. The fetoscope is then used to &quot;map&quot; the&#xD;
        placental vascular pattern. Communicating vessels between the fetuses are ablated using laser&#xD;
        energy via a 400-600 micron laser fiber that has been introduced through the instrument&#xD;
        channel of the operating sheath. Intravenous sedation with local anesthesia at the site of&#xD;
        insertion has been found to provide sufficient maternal anesthesia for the procedure. At the&#xD;
        completion of the S-PLC, the excess amniotic fluid in the recipient twin's sac is removed to&#xD;
        achieve a normal volume.&#xD;
  &#xD;
        Follow-Up: The investigators will follow patients for the immediate post-procedure period&#xD;
        (until they leave the OR).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2028</completion_date>
    <primary_completion_date type="Anticipated">December 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of adverse events</measure>
      <time_frame>Immediate Post-Procedure Period (from surgery start until surgery finish)</time_frame>
      <description>Number of adverse events associated with the investigational device.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of device defects, malfunctions, or failures</measure>
      <time_frame>Immediate Post-Procedure Period (from surgery start until surgery finish)</time_frame>
      <description>Number of device defects, malfunctions, or failures and whether the device performed as intended.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Twin Monochorionic Diamniotic Placenta</condition>
    <arm_group>
      <arm_group_label>Fetoscopes for Selective Laser Photocoagulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single arm study. All patients will undergo selective laser photocoagulation with the use of the fetoscopes in this study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Fetoscopy Sets for Anterior and Posterior Placentas</intervention_name>
      <description>Patients who choose to undergo fetoscopic surgery for a complicated monochorionic-diamniotic pregnancy will be offered participation in this study. All patients will undergo selective laser photocoagulation with the use of the fetoscopes in this study.</description>
      <arm_group_label>Fetoscopes for Selective Laser Photocoagulation</arm_group_label>
      <other_name>Karl Storz Miniature Straight Forward Telescope 0 Degrees Set - Straight or 11506 AAK</other_name>
      <other_name>Karl Storz Miniature Straight Forward Telescope 0 Degrees Set - Curved or 11508 AAK</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who are eligible and elect to undergo fetoscopic selective laser&#xD;
               photocoagulation for the treatment of complicated monochorionic-diamniotic&#xD;
               pregnancies.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who do not elect to undergo fetoscopic laser photocoagulation for treatment&#xD;
               of complicated monochorionic-diamniotic pregnancies.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael A Belfort, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Baylor College of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michael A Belfort, MD, PhD</last_name>
      <phone>832-826-7375</phone>
      <email>belfort@bcm.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Becky Johnson, MS</last_name>
      <phone>832-826-7451</phone>
      <email>rj2@bcm.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Texas Children's Hospital - Pavilion for Women</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Michael A Belfort, MD, PhD</last_name>
        <phone>832-826-7375</phone>
        <email>belfort@bcm.edu</email>
      </contact>
      <contact_backup>
        <last_name>Becky Johnson, MS</last_name>
        <phone>832-826-7451</phone>
        <email>rj2@bcm.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Michael A Belfort, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Magdalena Sanz Cortes, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Roopali Donepudi, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ahmed Nassr, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
      <investigator_full_name>Michael A Belfort</investigator_full_name>
      <investigator_title>Chairman and Professor</investigator_title>
    </responsible_party>
    <keyword>twin-twin transfusion syndrome</keyword>
    <keyword>TTTS</keyword>
    <keyword>twin anemia polycythemia sequence</keyword>
    <keyword>TAPS</keyword>
    <keyword>selective intrauterine growth restriction</keyword>
    <keyword>sIUGR</keyword>
    <!-- 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/NCT06022510
  org study id: H-53644
  nct id: NCT06022510
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  The purpose of this study is to evaluate the safety and efficacy of the investigational
        fetoscopes used in patients undergoing fetoscopic selective laser photocoagulation for
        complicated monochorionic-diamniotic pregnancies.
  All patients who choose to undergo fetoscopic selective laser photocoagulation (S-PLC) at
        Texas Children's Fetal Center will be offered participation in this research study by study
        investigators. Description of study rationale and design and a focused interview by the study
        coordinator to afford potential participants a formal opportunity to examine what they have
        learned about the research study in the course of their evaluation and discuss how they feel
        about enrolling in the research study. Once the patient is deemed eligible the informed
        consent process will be reviewed. If patients elect to participate in the study, informed
        consent will be obtained, and patients provided a copy of the signed consent.
  
        Fetoscopic Procedure: Selective laser photocoagulation (S-PLC) is standard of care for the
        treatment of complicated monochorionic twin pregnancies and will be performed with the same
        technique in this study as it is with the use of the currently approved fetoscopes. In the
        majority of cases, in utero access has been achieved using a small percutaneous incision
        under ultrasound guidance with the instruments inserted through the maternal abdomen, uterine
        wall and into the recipient fetus' gestational sac. The fetoscope is then used to "map" the
        placental vascular pattern. Communicating vessels between the fetuses are ablated using laser
        energy via a 400-600 micron laser fiber that has been introduced through the instrument
        channel of the operating sheath. Intravenous sedation with local anesthesia at the site of
        insertion has been found to provide sufficient maternal anesthesia for the procedure. At the
        completion of the S-PLC, the excess amniotic fluid in the recipient twin's sac is removed to
        achieve a normal volume.
  
        Follow-Up: The investigators will follow patients for the immediate post-procedure period
        (until they leave the OR).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of adverse events
  time frame: Immediate Post-Procedure Period (from surgery start until surgery finish)
  description: Number of adverse events associated with the investigational device.
  measure: Number of device defects, malfunctions, or failures
  time frame: Immediate Post-Procedure Period (from surgery start until surgery finish)
  description: Number of device defects, malfunctions, or failures and whether the device performed as intended.
  arm group label: Fetoscopes for Selective Laser Photocoagulation
  arm group type: Experimental
  description: Single arm study. All patients will undergo selective laser photocoagulation with the use of the fetoscopes in this study.
  intervention type: Device
  intervention name: Fetoscopy Sets for Anterior and Posterior Placentas
  description: Patients who choose to undergo fetoscopic surgery for a complicated monochorionic-diamniotic pregnancy will be offered participation in this study. All patients will undergo selective laser photocoagulation with the use of the fetoscopes in this study.
  arm group label: Fetoscopes for Selective Laser Photocoagulation
  other name: Karl Storz Miniature Straight Forward Telescope 0 Degrees Set - Straight or 11506 AAK
  other name: Karl Storz Miniature Straight Forward Telescope 0 Degrees Set - Curved or 11508 AAK
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michael A Belfort, MD
  role: Principal Investigator
  affiliation: Baylor College of Medicine
  last name: Michael A Belfort, MD, PhD
  phone: 832-826-7375
  email: belfort@bcm.edu
  last name: Becky Johnson, MS
  phone: 832-826-7451
  email: rj2@bcm.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Baylor College of Medicine
  investigator full name: Michael A Belfort
  investigator title: Chairman and Professor