[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100249773":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":48,"collaborators":30,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":30,"enrollmentInfo":61,"targetDuration":30,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":34,"whyStopped":30,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Connecticut Children's Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fetoscopic Endoluminal Tracheal Occlusion (FETO)","EXPERIMENTAL","An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)",[13],"Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","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 and observed\u002Fexpected length head ratio \\\u003C25% (O\u002FE LHR).",[9],[20],"BALT GOLDBAL2 Tracheal Balloon Catheter system",[22],{"name":23,"affiliation":5,"role":24},"Timothy Crombleholme, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Katie E Boyle, MPH","CONTACT","860-837-6547",null,"Kboyle01@connecticutchildrens.org",[33],{"facility":5,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Hartford","Connecticut","06106","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-72.68509,41.76371,{"lat":44,"lon":43},[47],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},{"type":24,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Timothy Crombleholme","Director of Fetal Care Center","100249773","trial-of-fetoscopic-endoluminal-tracheal-occlusion-feto-for-cdh-100249773",false,"NCT02530073","Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH","Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe 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 CDH with liver up\n* Gestation at enrollment prior to 29 wks plus 6 days\n* SEVERE pulmonary hypoplasia with Ultra Sound O\u002FE LHR \\\u003C 25%\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* Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O\u002FE LHR ≥ 25%\n* Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care","FEMALE","18 Years",{"count":62,"type":63},15,"ESTIMATED","INTERVENTIONAL",[66],"NA","The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.",[69],"Congenital Diaphragmatic Hernias",[71,57,72],"congenital diaphragmatic hernia","tracheal occlusion","2026-06-16",{"date":75,"type":76},"2026-06-18","ACTUAL",{"date":78,"type":76},"2015-09",{"date":80,"type":63},"2030-08",{"name":5,"class":6},1]