<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/NCT02986087</url>
  </required_header>
  <id_info>
    <org_study_id>2015-6413</org_study_id>
    <nct_id>NCT02986087</nct_id>
  </id_info>
  <brief_title>Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia</brief_title>
  <acronym>FETO</acronym>
  <official_title>Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</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>
      Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fetuses with congenital diaphragmatic hernia with liver-up, and an observed to expected&#xD;
      lung-to-head ratio of &lt;25%, LHR &lt;1, or a moderate category with o/e LHR &lt;30%, singleton&#xD;
      pregnancy, no known other anomalies, gestational age &lt; 29 weeks 6 days (severe), gestational&#xD;
      age &lt; 31 weeks 6 days (moderate), no maternal disease, maternal age &gt; 18 years old…. meet&#xD;
      criteria to be offered fetal tracheal occlusion. We want to test feasibility and efficacy in&#xD;
      our center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <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>Change lung growth on prenatal imaging</measure>
    <time_frame>prenatal period up to 40 weeks gestation</time_frame>
    <description>Change in o/eLHR and other prenatal imaging tests</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change survival in the severe congenital diaphragmatic hernia subgroup</measure>
    <time_frame>6 months</time_frame>
    <description>Change rate of survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change need for ECMO therapy</measure>
    <time_frame>6 months</time_frame>
    <description>Change need for ECMO therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change pulmonary hypertension</measure>
    <time_frame>6 months</time_frame>
    <description>Change pulmonary hypertension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change neonatal morbidity</measure>
    <time_frame>1 year</time_frame>
    <description>Change neonatal morbidity</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Congenital Diaphragmatic Hernia</condition>
  <condition>Pulmonary Hypoplasia</condition>
  <condition>Pulmonary; Hypertension</condition>
  <arm_group>
    <arm_group_label>Fetal Tracheal Occlusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fetal Tracheal Occlusion</intervention_name>
    <description>Fetuses with congenital diaphragmatic hernia with an observed to expected lung-to-head ratio of &lt;25%, LHR &lt;1, o/e LHR&lt;30% (moderate), singleton pregnancy, no known other anomalies, gestational age &lt; 29 weeks 6 days, no maternal disease, maternal age &gt; 18 years old meet criteria to be offered tracheal occlusion. We want to test feasibility and efficacy in our center as a requirement to enter the TOTAL trial.</description>
    <arm_group_label>Fetal Tracheal Occlusion</arm_group_label>
    <other_name>FETO</other_name>
    <other_name>Fetal Endoluminal Tracheal Occlusion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Isolated CDH with liver up&#xD;
&#xD;
          -  Severe pulmonary hypoplasia with ultrasound O/E LHR &lt;25% at the time of surgery&#xD;
&#xD;
          -  Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days&#xD;
&#xD;
          -  Moderate pulmonary hypoplasia with ultrasound O/E LHR &lt;30% and liver-up at the time of&#xD;
             surgery&#xD;
&#xD;
          -  Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate&#xD;
             category&#xD;
&#xD;
          -  Maternal age greater than or equal to 18 years&#xD;
&#xD;
          -  Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate&#xD;
             category&#xD;
&#xD;
          -  Normal karyotype or FISH&#xD;
&#xD;
          -  Normal fetal echocardiogram&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Willing to remain in the greater Cincinnati area for remainder of pregnancy&#xD;
&#xD;
          -  Family considered and decline option of termination of the pregnancy at less than 24&#xD;
             weeks 0 days&#xD;
&#xD;
          -  Family meets psychosocial criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient &lt; 18 years old&#xD;
&#xD;
          -  Multi-fetal pregnancy&#xD;
&#xD;
          -  Rubber latex allergy&#xD;
&#xD;
          -  Preterm labor, cervix shortened (&lt;15 mm) or uterine anomaly strongly predisposing to&#xD;
             preterm labor, placenta previa&#xD;
&#xD;
          -  Bilateral CDH, isolated left sided CDH with an O/E &gt; 30%&#xD;
&#xD;
          -  Additional fetal anomaly by ultrasound, MRI, or echocardiogram&#xD;
&#xD;
          -  Chromosomal abnormalities&#xD;
&#xD;
          -  Maternal contraindications to fetoscopic surgery or severe maternal condition in&#xD;
             pregnancy&#xD;
&#xD;
          -  Incompetent cervix with or without a cerclage&#xD;
&#xD;
          -  Placental abnormalities known at time of enrollment&#xD;
&#xD;
          -  Maternal HIV, Hepatits B, Hepatitis C&#xD;
&#xD;
          -  Maternal uterine anomaly&#xD;
&#xD;
          -  No safe or technically feasible fetoscopic approach to balloon placement&#xD;
&#xD;
          -  Participation in another intervention study that influences maternal and fetal&#xD;
             morbidity and mortality or participation in this trial in a previous pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kurt Schibler, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CCHMC Oversight Data Safety Monitoring Committee</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Foong-Yen Lim, MD</last_name>
    <phone>(513) 636-6259</phone>
    <email>Foong-Yen.Lim@cchmc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jose Peiro, MD, PhD</last_name>
    <phone>(513) 803-4563</phone>
    <email>Jose.Peiro@cchmc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center (CCHMC)</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Foong-Yen Lim, MD</last_name>
      <phone>513-803-5270</phone>
      <email>Foong.Yen.Lim@cchmc.org</email>
    </contact>
    <contact_backup>
      <last_name>Jose L Peiro, MD, PhD, MBA</last_name>
      <phone>513-803-4563</phone>
      <email>jose.peiroibanez@cchmc.org</email>
    </contact_backup>
    <investigator>
      <last_name>Jose L Peiro, MD, MBA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Foong Y Lim, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>July 5, 2023</last_update_submitted>
  <last_update_submitted_qc>July 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2023</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>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hernias, Diaphragmatic, Congenital</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Diaphragmatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02986087
org study id: 2015-6413
nct id: NCT02986087
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
Fetuses with congenital diaphragmatic hernia with liver-up, and an observed to expected
      lung-to-head ratio of <25%, LHR <1, or a moderate category with o/e LHR <30%, singleton
      pregnancy, no known other anomalies, gestational age < 29 weeks 6 days (severe), gestational
      age < 31 weeks 6 days (moderate), no maternal disease, maternal age > 18 years old…. meet
      criteria to be offered fetal tracheal occlusion. We want to test feasibility and efficacy in
      our center.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change lung growth on prenatal imaging
time frame: prenatal period up to 40 weeks gestation
description: Change in o/eLHR and other prenatal imaging tests
measure: Change survival in the severe congenital diaphragmatic hernia subgroup
time frame: 6 months
description: Change rate of survival
measure: Change need for ECMO therapy
time frame: 6 months
description: Change need for ECMO therapy
measure: Change pulmonary hypertension
time frame: 6 months
description: Change pulmonary hypertension
measure: Change neonatal morbidity
time frame: 1 year
description: Change neonatal morbidity
arm group label: Fetal Tracheal Occlusion
arm group type: Experimental
description: Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.
intervention type: Device
intervention name: Fetal Tracheal Occlusion
description: Fetuses with congenital diaphragmatic hernia with an observed to expected lung-to-head ratio of <25%, LHR <1, o/e LHR<30% (moderate), singleton pregnancy, no known other anomalies, gestational age < 29 weeks 6 days, no maternal disease, maternal age > 18 years old meet criteria to be offered tracheal occlusion. We want to test feasibility and efficacy in our center as a requirement to enter the TOTAL trial.
arm group label: Fetal Tracheal Occlusion
other name: FETO
other name: Fetal Endoluminal Tracheal Occlusion
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kurt Schibler, MD
role: Study Chair
affiliation: CCHMC Oversight Data Safety Monitoring Committee
last name: Foong-Yen Lim, MD
phone: (513) 636-6259
email: Foong-Yen.Lim@cchmc.org
last name: Jose Peiro, MD, PhD
phone: (513) 803-4563
email: Jose.Peiro@cchmc.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Hernias, Diaphragmatic, Congenital
mesh term: Hernia
mesh term: Hernia, Diaphragmatic
sharing ipd: No