[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100337509":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":31,"centralContacts":32,"locations":42,"responsibleParty":65,"collaborators":31,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":31,"enrollmentInfo":77,"targetDuration":31,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":45,"whyStopped":31,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Fetuses with Left CDH (O\u002FE LHR \u003C 25%)","EXPERIMENTAL","Fetuses with Left CDH (O\u002FE LHR \\\u003C 25%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)",[13],"Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)",{"label":15,"type":10,"description":16,"interventionNames":17},"Fetuses with L- sided CDH with O\u002FE LHR \u003C30%.","Fetuses with Left CDH (O\u002FE LHR \\\u003C 30%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Fetuses with R- sided CDH with O\u002FE LHR \u003C 45%","Fetuses with Right CDH (O\u002FE LHR \\\u003C 45%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Fetoscopic Endoluminal Tracheal Occlusion (FETO)","This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH (O\u002FE \\\u003C 25%; O\u002FE LHR \\\u003C 30 %) and right CDH (O\u002FE LHR \\\u003C 45%).",[15,9,19],[29,30],"BALT GOLDBALLOON: GoldBAL2 Detachable Balloon","BALTACCIBDPE100: Catheter System",null,[33,38],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Elizabeth Torres","CONTACT","720-777-1661","elizabeth.torres@childrenscolorado.org",{"name":39,"role":35,"phone":40,"phoneExt":31,"email":41},"Halley Isberg","720-777-9514","halley.isberg@childrenscolorado.org",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Children's Hospital Colorado","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-104.83192,39.72943,{"lat":55,"lon":54},[58,59,62],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},{"name":60,"role":61,"phone":31,"phoneExt":31,"email":31},"Sarkis Derderian, MD","PRINCIPAL_INVESTIGATOR",{"name":63,"role":64,"phone":31,"phoneExt":31,"email":31},"Michael Zaretsky, MD","SUB_INVESTIGATOR",{"type":66,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100337509","fetoscopic-endoluminal-tracheal-occlusion-100337509",false,"NCT03674372","Fetoscopic Endoluminal Tracheal Occlusion","Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Right and Left Congenital Diaphragmatic Hernia (CDH)","FETO","Inclusion Criteria:\n\n* Pregnant women age 18 years and older, who are able to consent\n* Singleton pregnancy\n\nFetal\n\n* Normal Karyotype\n* Fetal Diagnosis of Isolated Left or Right CDH with liver up\n* Gestation at enrollment prior to 29 wks plus 6 days\n* SEVERE pulmonary hypoplasia with Ultra Sound L-sided O\u002FE LHR \\\u003C 25% or R-sided O\u002FE LHR \\\u003C45%\n\nExclusion Criteria:\n\n* Pregnant women \\\u003C18 years of age.\n* Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy\n* Technical limitations precluding fetoscopic surgery\n* 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 remain at FETO site during time period of tracheal occlusion, delivery and postnatal care","FEMALE","18 Years",{"count":78,"type":79},10,"ESTIMATED","INTERVENTIONAL",[82],"NA","The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.",[85],"Congenital Diaphragmatic Hernia",[87,73,85],"tracheal occlusion","2025-06-05",{"date":90,"type":91},"2025-06-10","ACTUAL",{"date":93,"type":91},"2018-11-16",{"date":95,"type":79},"2030-03",{"name":5,"class":6},1]