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/NCT05962346</url>
    </required_header>
    <id_info>
      <org_study_id>23-002166</org_study_id>
      <nct_id>NCT05962346</nct_id>
    </id_info>
    <brief_title>Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia</brief_title>
    <acronym>FETO</acronym>
    <official_title>Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion for Severe Left Congenital Diaphragmatic Hernia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mauro H. Schenone</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this research is to gather information on the safety and effectiveness of a&#xD;
        procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent&#xD;
        of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe&#xD;
        congenital diaphragmatic hernia (CDH).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">July 2043</completion_date>
    <primary_completion_date type="Anticipated">July 2043</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>Technical success of the balloon placement procedure</measure>
      <time_frame>Up to 29 weeks gestation</time_frame>
      <description>The number of successful balloon placement procedures defined as balloon was correctly inflated and placed/secured in the trachea.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Technical success of balloon retrieval procedure</measure>
      <time_frame>Up to 34 weeks gestation</time_frame>
      <description>The number of successful balloon retrieval procedure defined as antenatal removal of the balloon.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Operative times</measure>
      <time_frame>Up to 34 weeks gestation</time_frame>
      <description>FETO placement and release operative times reported in minutes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Frequency of unplanned balloon removal</measure>
      <time_frame>Up to 34 weeks gestation</time_frame>
      <description>The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of incidences of maternal complications</measure>
      <time_frame>Up to 41 weeks gestation</time_frame>
      <description>Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gestational Age at Delivery</measure>
      <time_frame>Up to 41 weeks gestation</time_frame>
      <description>Gestation Age reported at time of delivery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fetal Lung Growth as measured via Fetal Lung Volume</measure>
      <time_frame>Up to 24 months post partum</time_frame>
      <description>Fetal Lung Volume as measured via ultrasound</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fetal Lung Growth as measured via LHR</measure>
      <time_frame>Up to 24 months post partum</time_frame>
      <description>Lung area to head circumference Ratio (LHR) as measured via ultrasound</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fetal Survival</measure>
      <time_frame>Up to 6 months post partum</time_frame>
      <description>Survival at 30 days, discharge from the hospital and at 6 months if still hospitalized</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fetal Oxygen Dependency</measure>
      <time_frame>Up to 24 months post partum</time_frame>
      <description>Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of severe pulmonary hypertension</measure>
      <time_frame>Up to 24 months post partum</time_frame>
      <description>Number of occurrence of severe pulmonary hypertension in infants based on echocardiogram</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ECMO Support</measure>
      <time_frame>Up to 24 months post partum</time_frame>
      <description>Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of days in NICU</measure>
      <time_frame>Up to 24 months post partum</time_frame>
      <description>Number of days infant was in neonatal intensive care unit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of days of ventilator support</measure>
      <time_frame>Up to 24 months post partum</time_frame>
      <description>Number of reported days infants required ventilator support</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of periventricular leukomalacia at &lt; 2 months postnatally</measure>
      <time_frame>Up to 2 months post partum</time_frame>
      <description>Number of infants reported presence of periventricular leukomalacia at &lt; 2 months postnatally</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of infant complications</measure>
      <time_frame>Up to 24 months post partum</time_frame>
      <description>Number of infants reporting the presence of: neonatal sepsis, intraventricular hemorrhage (grade 3 or higher), retinopathy of prematurity (grade 3 or higher) or gastro-esophageal reflux</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Use of patch or muscle flap</measure>
      <time_frame>Up to 24 months post partum</time_frame>
      <description>Number of infants reported to require the use of patch or muscle flap</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal hospitalization</measure>
      <time_frame>Up to 24 months post partum</time_frame>
      <description>Number of reported days of maternal hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Route of delivery</measure>
      <time_frame>Day 1 (post partum)</time_frame>
      <description>Number of participants that delivered vaginally and via caesarean section</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Congenital Diaphragmatic Hernia</condition>
    <arm_group>
      <arm_group_label>FETO Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure between 27 weeks 0 days and 29 weeks 6 days gestation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>BALT GOLDBALL 2 detachable latex ballon</intervention_name>
      <description>Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.</description>
      <arm_group_label>FETO Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>BALTACCIBDPE100 Microcatheter</intervention_name>
      <description>Used to deliver the detachable balloon</description>
      <arm_group_label>FETO Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Storz fetoscopic operating sheath and miniature telescope/fetoscope</intervention_name>
      <description>Used to percutaneously enter though the maternal abdominal wall, uterus and into the amniotic cavity, fetal mouth, pharynx, larynx, into the trachea where the delivery catheter will be used to deliver the detachable balloon that will provide with the tracheal occlusion.</description>
      <arm_group_label>FETO Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Singleton pregnancy&#xD;
  &#xD;
            -  Normal fetal karyotype or microarray. Results by fluorescence in situ hybridization&#xD;
               (FISH) will be acceptable if the patient is &gt; 26 weeks&#xD;
  &#xD;
            -  Isolated severe left CDH with O/E LHR &lt; 25% )&#xD;
  &#xD;
            -  Gestation age at enrollment prior to 29 wks plus 6 days.&#xD;
  &#xD;
            -  Pulmonary hypoplasia with ultrasound O/E LHR &lt; 25% (measured at 18 0/7 to 29 5/7&#xD;
               weeks) at the time of surgery.&#xD;
  &#xD;
            -  Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by&#xD;
               clinical information (LMP) and evaluation of first ultrasound&#xD;
  &#xD;
            -  Patient meets psychosocial criteria: able to reside within 30 minutes of Mayo Clinic,&#xD;
               Rochester and able to comply with the travel for the follow-up requirements of the&#xD;
               trial; patient has a support person (e.g. spouse, partner, mother) available to stay&#xD;
               with the patient for the duration of the pregnancy at Mayo Clinic&#xD;
  &#xD;
            -  Patient is willing and able to give informed consent&#xD;
  &#xD;
            -  Appropriate multi-disciplinary counseling performed with maternal-fetal medicine,&#xD;
               neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Multi-fetal pregnancy&#xD;
  &#xD;
            -  History of natural rubber latex allergy&#xD;
  &#xD;
            -  Preterm labor, cervix shortened (&lt;20 mm) at enrollment or within 24 hours of FETO&#xD;
               balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor&#xD;
  &#xD;
            -  Psychosocial ineligibility, precluding consent: inability to reside within 30 minutes&#xD;
               of Mayo Clinic, Rochester and inability to comply with the travel for the follow-up&#xD;
               requirements of the trial; patient does not have a support person (e.g. spouse,&#xD;
               partner, mother) available to stay with the patient for the duration of the pregnancy&#xD;
               at Mayo Clinic&#xD;
  &#xD;
            -  Right sided CDH or bilateral CDH, isolated left sided with O/E LHR &gt;25% measured at 18&#xD;
               0/7 to 29 6/7 weeks) as determined by ultrasound&#xD;
  &#xD;
            -  Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or&#xD;
               echocardiogram that will significantly worsen prognosis. No cases will be removed post&#xD;
               hoc if abnormalities are discovered in the course of post-operative monitoring&#xD;
  &#xD;
            -  Maternal contraindication to fetoscopic surgery&#xD;
  &#xD;
            -  History of incompetent cervix with or without cerclage&#xD;
  &#xD;
            -  Placental abnormalities (previa, abruption, accreta) known at time of enrollment&#xD;
  &#xD;
            -  Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune&#xD;
               thrombocytopenia affecting the current pregnancy&#xD;
  &#xD;
            -  Maternal HIV, Hepatitis-B, Hepatitis-C status positive.&#xD;
  &#xD;
            -  Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality that&#xD;
               will make the procedure technically unfeasible&#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>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mauro Schenone, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mayo Clinic Minnesota</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Mauro H. Schenone</investigator_full_name>
      <investigator_title>Regulatory Sponsor and Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>
  
  
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/NCT05962346
  org study id: 23-002166
  nct id: NCT05962346
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  The purpose of this research is to gather information on the safety and effectiveness of a
        procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent
        of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe
        congenital diaphragmatic hernia (CDH).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Technical success of the balloon placement procedure
  time frame: Up to 29 weeks gestation
  description: The number of successful balloon placement procedures defined as balloon was correctly inflated and placed/secured in the trachea.
  measure: Technical success of balloon retrieval procedure
  time frame: Up to 34 weeks gestation
  description: The number of successful balloon retrieval procedure defined as antenatal removal of the balloon.
  measure: Operative times
  time frame: Up to 34 weeks gestation
  description: FETO placement and release operative times reported in minutes
  measure: Frequency of unplanned balloon removal
  time frame: Up to 34 weeks gestation
  description: The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)
  measure: Number of incidences of maternal complications
  time frame: Up to 41 weeks gestation
  description: Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
  measure: Gestational Age at Delivery
  time frame: Up to 41 weeks gestation
  description: Gestation Age reported at time of delivery
  measure: Fetal Lung Growth as measured via Fetal Lung Volume
  time frame: Up to 24 months post partum
  description: Fetal Lung Volume as measured via ultrasound
  measure: Fetal Lung Growth as measured via LHR
  time frame: Up to 24 months post partum
  description: Lung area to head circumference Ratio (LHR) as measured via ultrasound
  measure: Fetal Survival
  time frame: Up to 6 months post partum
  description: Survival at 30 days, discharge from the hospital and at 6 months if still hospitalized
  measure: Fetal Oxygen Dependency
  time frame: Up to 24 months post partum
  description: Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician
  measure: Occurrence of severe pulmonary hypertension
  time frame: Up to 24 months post partum
  description: Number of occurrence of severe pulmonary hypertension in infants based on echocardiogram
  measure: ECMO Support
  time frame: Up to 24 months post partum
  description: Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support
  measure: Number of days in NICU
  time frame: Up to 24 months post partum
  description: Number of days infant was in neonatal intensive care unit
  measure: Number of days of ventilator support
  time frame: Up to 24 months post partum
  description: Number of reported days infants required ventilator support
  measure: Number of periventricular leukomalacia at < 2 months postnatally
  time frame: Up to 2 months post partum
  description: Number of infants reported presence of periventricular leukomalacia at < 2 months postnatally
  measure: Number of infant complications
  time frame: Up to 24 months post partum
  description: Number of infants reporting the presence of: neonatal sepsis, intraventricular hemorrhage (grade 3 or higher), retinopathy of prematurity (grade 3 or higher) or gastro-esophageal reflux
  measure: Use of patch or muscle flap
  time frame: Up to 24 months post partum
  description: Number of infants reported to require the use of patch or muscle flap
  measure: Maternal hospitalization
  time frame: Up to 24 months post partum
  description: Number of reported days of maternal hospitalization
  measure: Route of delivery
  time frame: Day 1 (post partum)
  description: Number of participants that delivered vaginally and via caesarean section
  arm group label: FETO Group
  arm group type: Experimental
  description: Participants will undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure between 27 weeks 0 days and 29 weeks 6 days gestation.
  intervention type: Device
  intervention name: BALT GOLDBALL 2 detachable latex ballon
  description: Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.
  arm group label: FETO Group
  intervention type: Device
  intervention name: BALTACCIBDPE100 Microcatheter
  description: Used to deliver the detachable balloon
  arm group label: FETO Group
  intervention type: Device
  intervention name: Storz fetoscopic operating sheath and miniature telescope/fetoscope
  description: Used to percutaneously enter though the maternal abdominal wall, uterus and into the amniotic cavity, fetal mouth, pharynx, larynx, into the trachea where the delivery catheter will be used to deliver the detachable balloon that will provide with the tracheal occlusion.
  arm group label: FETO Group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Mauro Schenone, MD
  role: Principal Investigator
  affiliation: Mayo Clinic
  facility: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Sponsor-Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Mauro H. Schenone
  investigator title: Regulatory Sponsor and Principal Investigator
  mesh term: Hernias, Diaphragmatic, Congenital
  mesh term: Hernia
  mesh term: Hernia, Diaphragmatic
  sharing ipd: No