[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulmonary-hypoplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulmonary-hypoplasia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,75,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100296428","fetal-endoscopic-tracheal-occlusion-for-congenital-diaphragmatic-hernia-feto-100296428",false,"NCT03138863","Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)","Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863","FETO","Inclusion Criteria:\n\n* Singleton pregnancy\n* Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \\> 26 weeks.\n* Isolated Left CDH with liver up\n* Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O\u002FE lung area to head circumference ratio (LHR) \\\u003C 25% (measured at 180 to 296 weeks) at the time of surgery; O\u002FE LHR 25% to \\\u003C30% (measured at 300 to 316 weeks) at time of surgery.\n* Gestational age at FETO procedure with O\u002FE LHR \\\u003C25% at 27 weeks 0 days to 29 weeks 6 days; with O\u002FE LHR 25% to \\\u003C30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound\n* Patient meets psychosocial criteria\n\nExclusion Criteria:\n\n* Multi-fetal pregnancy\n* History of natural rubber latex allergy\n* Preterm labor, cervix shortened (\\\u003C15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa\n* Psychosocial ineligibility, precluding consent:\n* Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial\n* Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at our institution.\n* Right sided CDH or bilateral CDH, isolated left sided with O\u002FE LHR ≥30% (measured at 180 to 295 weeks) as determined by ultrasound\n* Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of postoperative monitoring\n* Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy\n* History of incompetent cervix with or without cerclage\n* Placental abnormalities (previa, abruption, accrete) known at time of enrollment\n* Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy\n* Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality\n* Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy","FEMALE","18 Years","50 Years",{"count":21,"type":22},10,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).",[28,29,30],"Congenital Diaphragmatic Hernia","Pulmonary Hypoplasia","Pulmonary Artery Hypertension",[32,33,34,35,36],"fetal lungs","fetal surgery","congenital diaphragmatic hernia","tracheal occlusion","pulmonary hypoplasia","RECRUITING","2026-02-19",{"date":40,"type":41},"2026-02-23","ACTUAL",{"date":43,"type":41},"2024-05-01",{"date":45,"type":22},"2030-11-01",{"name":47,"class":48},"Rodrigo Ruano","OTHER",2,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100607334","phase-3-safety-and-efficacy-of-feto-in-cdh-phase-iii-100607334","NCT07187206","Safety and Efficacy of FETO in CDH Phase III","CDH FETO","Inclusion Criteria:\n\n* Pregnant women 18 years and older, who are able to consent\n* Singleton pregnancy\n* Gestational age at enrollment is prior to 296 weeks\n* Intrathoracic liver herniation\n* Isolated Left CDH with o\u002Fe LHR \\\u003C 30% at enrollment (180 to 295 weeks) or\n* Isolated Right CDH with o\u002Fe LHR \\\u003C 45% at enrollment (180 to 295 weeks)\n* Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \\> 26 weeks\n* Cervical length by transvaginal ultrasound \\> 20 mm within 24 hours prior to FETO procedure\n* Patient meets psychosocial criteria\n* Informed consent understood\n\nExclusion Criteria\n\n* Patient \\\u003C 18 years of age\n* Multi-fetal pregnancy\n* History of natural rubber latex allergy\n* Preterm labor, cervix shortened (\\\u003C 20 mm at enrollment or within 24 hours prior to FETO balloon insertion) or uterine anomaly strongly predisposing to preterm labor, or placenta previa.\n* Psychosocial ineligibility, precluding consent:\n\n  * Inability to reside within 30 minutes of Cincinnati Children's Hospital Medical Center and inability to comply with the travel for the follow-up requirements of the trial.\n  * The patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Cincinnati Children's Hospital Medical Center.\n* Bilateral CDH, isolated LCDH with o\u002Fe LHR ≥ 30%, isolated RCDH with o\u002Fe LHR \\> 45%, as determined by ultrasound.\n* No liver herniation into thoracic cavity\n* Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center.\n* Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy\n* History of incompetent cervix with or without cerclage\n* Placental abnormalities (previa, abruption, accreta) known at time of enrollment\n* Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy\n* Maternal HIV, Hepatitis-B, Hepatitis-C positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV status is unknown, the patient must be tested and found to have negative results before enrollment.\n* Positive Hepatitis B surface antigen or presence of Hepatitis C in maternal blood uterine anomaly such as Mullerian duct abnormality, large or multiple fibroids that prohibit safe fetoscopic procedure\n* There is no safe or technically feasible fetoscopic approach to balloon placement\n* Participation in another intervention study that influences maternal and fetal morbidity and mortality, or participation in this trial in a previous pregnancy",true,{"count":59,"type":22},75,[61],"PHASE3","Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group",[28,29,64],"Pulmonary Hypertension","2025-09-16",{"date":67,"type":41},"2025-09-22",{"date":69,"type":22},"2025-09-30",{"date":71,"type":22},"2033-03-01",{"name":73,"class":48},"Children's Hospital Medical Center, Cincinnati",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":49},"100584060","safety-and-efficacy-of-feto-in-cdh-a-phase-iii-trial-100584060","NCT06884423","Safety and Efficacy of FETO in CDH: A Phase III Trial","Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial","CHOP FETO","Inclusion Criteria:\n\n1. Pregnant women age 18 years and older\n2. Singleton pregnancy\n3. Normal fetal karyotype with confirmation by culture results, whole exome sequencing (WES), whole genome sequencing (WGS), or chromosomal microarray with non-pathologic variants. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is greater than 26 weeks.\n4. Gestational age at enrollment is prior to 29 weeks 6 days\n5. Liver is intrathoracic\n6. Isolated left congenital diaphragmatic hernia (CDH) with observed\u002Fexpected lung to head ratio (O\u002FE LHR) of less than 30% at enrollment (18\\^0 to 29\\^5 weeks), or:\n7. Isolated right CDH with O\u002FE LHR equal to or less than 45% at enrollment (18\\^0 to 29\\^5 weeks).\n8. Cervical length by transvaginal ultrasound equal to or greater than 20 mm within 24 hours of fetoscopic endoluminal tracheal occlusion (FETO) procedure\n9. Patient meets psychosocial criteria\n10. Informed consent\n\nExclusion Criteria:\n\n1. Patient is less than 18 years of age\n2. Multi-fetal pregnancy\n3. History of natural rubber latex allergy\n4. Preterm labor, cervix shortened (less than 20 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa\n5. Psychosocial ineligibility, precluding consent:\n\n   * Inability to reside within 30 minutes of the Children's Hospital of Philadelphia (CHOP) and inability to comply with the travel for the follow-up requirements of the trial\n   * Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at CHOP\n6. Bilateral CDH, isolated left sided CDH with O\u002FE LHR greater than or equal to 30% (measured at 18\\^0 to 29\\^5 weeks), isolated right sided CDH with O\u002FE LHR greater than 45% (measured at 180 to 295 weeks), as determined by ultrasound\n7. No Liver herniation into thoracic cavity.\n8. Additional fetal anomaly by ultrasound, magnetic resonance imaging (MRI), or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (ie. CDH and congenital heart disease) or presence of an underlying genetic syndrome (ie. Fryns).\n9. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy\n10. History of incompetent cervix with or without cerclage\n11. Placental abnormalities (previa, abruption, accrete) known at time of enrollment.\n12. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.\n13. Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment.\n14. Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality\n15. There is no safe or technically feasible fetoscopic approach to balloon placement.\n16. Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.",{"count":84,"type":22},80,[25],"Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally.\n\nIn severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.",[28,29],[34,35],"2025-07-22",{"date":91,"type":41},"2025-07-25",{"date":93,"type":41},"2025-04-07",{"date":95,"type":22},"2032-04",{"name":97,"class":48},"Holly L Hedrick, MD",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":15,"eligibilityCriteria":103,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":74},"100284706","feto-endoscopic-tracheal-occlusion-feto-for-severe-congenital-diaphragmatic-hernia-100284706","NCT02986087","Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia","Inclusion Criteria:\n\n* Isolated CDH with liver up\n* Severe pulmonary hypoplasia with ultrasound O\u002FE LHR \\\u003C25% at the time of surgery\n* Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days\n* Moderate pulmonary hypoplasia with ultrasound O\u002FE LHR \\\u003C30% and liver-up at the time of surgery\n* Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category\n* Maternal age greater than or equal to 18 years\n* Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category\n* Normal karyotype or FISH\n* Normal fetal echocardiogram\n* Singleton pregnancy\n* Willing to remain in the greater Cincinnati area for remainder of pregnancy\n* Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days\n* Family meets psychosocial criteria\n\nExclusion Criteria:\n\n* Patient \\\u003C 18 years old\n* Multi-fetal pregnancy\n* Rubber latex allergy\n* Preterm labor, cervix shortened (\\\u003C15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa\n* Bilateral CDH, isolated left sided CDH with an O\u002FE \\> 30%\n* Additional fetal anomaly by ultrasound, MRI, or echocardiogram\n* Chromosomal abnormalities\n* Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy\n* Incompetent cervix with or without a cerclage\n* Placental abnormalities known at time of enrollment\n* Maternal HIV, Hepatits B, Hepatitis C\n* Maternal uterine anomaly\n* No safe or technically feasible fetoscopic approach to balloon placement\n* Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy",{"count":105,"type":22},40,[25],"Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.",[28,29,109],"Pulmonary; Hypertension","2025-05-07",{"date":112,"type":41},"2025-05-11",{"date":114,"type":41},"2016-11",{"date":116,"type":22},"2026-12",{"name":73,"class":48}]