[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100361020":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":86,"collaborators":90,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":18,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":18,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":44,"whyStopped":18,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Baylor College of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fetal Endotracheal Occlusion (FETO)","EXPERIMENTAL","Placement and retrieval of the GoldBAL4 or GoldBAL2 Detachable balloon using the plug\u002Funplug method, using BALTACCIDBPE100 Delivery Catheter.",[13],"Device: Goldbal Detachable Balloon and delivery microcatheter",{"label":15,"type":16,"description":17,"interventionNames":18},"non-FETO","NO_INTERVENTION","The control group will consist of patients who did not undergo the FETO procedure who fit the same fetal inclusion\u002Fexclusion criteria as our FETO subjects and will be matched by variables including maternal age, body mass index, gestational age, severity of CDH and site of CDH (left- or right-sided).",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Goldbal Detachable Balloon and delivery microcatheter","Between 28+0\u002F7 - 31+6\u002F7 weeks gestation for severe CDH placement of the detachable balloon. Balloon retrieval will be planned for no later than 36+6\u002F7 weeks at the discretion of the FETO center.",[9],[26,27],"GOLDBAL4 or GOLDBAL2 Goldballoon","BALTACCIBDPE100 delivery microcatheter",[29],{"name":30,"affiliation":5,"role":31},"Michael Belfort, MD PhD","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":18,"email":36},"CONTACT","832-826-7375","belfort@bcm.edu",{"name":38,"role":34,"phone":39,"phoneExt":18,"email":40},"Rebecca M Johnson, MS","832-826-7451","rj2@bcm.edu",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Texas Childrens Hospital","RECRUITING","Houston","Texas","77030","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-95.36327,29.76328,{"lat":54,"lon":53},[57,59,61,63,66,68,70,72,74,76,78,80,82,84],{"name":58,"role":34,"phone":35,"phoneExt":18,"email":18},"Michael Belfort, M.D.",{"name":60,"role":34,"phone":39,"phoneExt":18,"email":18},"Rebecca Johnson, MS",{"name":62,"role":31,"phone":18,"phoneExt":18,"email":18},"Michael A Belfort, M.D., PhD",{"name":64,"role":65,"phone":18,"phoneExt":18,"email":18},"Timothy Lee, M.D.","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":18,"phoneExt":18,"email":18},"Magdalena Sanz Cortes, M.D., PhD",{"name":69,"role":65,"phone":18,"phoneExt":18,"email":18},"Ahmed Nassr, M.D., PhD",{"name":71,"role":65,"phone":18,"phoneExt":18,"email":18},"Wesley Lee, M.D.",{"name":73,"role":65,"phone":18,"phoneExt":18,"email":18},"Alice King, M.D.",{"name":75,"role":65,"phone":18,"phoneExt":18,"email":18},"Roopali Donepudi, M.D.",{"name":77,"role":65,"phone":18,"phoneExt":18,"email":18},"Sundeep Keswani, M.D.",{"name":79,"role":65,"phone":18,"phoneExt":18,"email":18},"Caitlin Sutton, M.D.",{"name":81,"role":65,"phone":18,"phoneExt":18,"email":18},"Betul Yilmaz, M.D.",{"name":83,"role":65,"phone":18,"phoneExt":18,"email":18},"Ryan Coleman, M.D.",{"name":85,"role":65,"phone":18,"phoneExt":18,"email":18},"Luc Joyeux, M.D., PhD",{"type":87,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Michael A Belfort","Chairman and Professor",[91],{"name":5,"class":6},"100361020","fetal-endotracheal-occlusion-feto-in-the-resolution-of-pulmonary-hypertension-in-fetuses-with-severe-cdh-100361020",false,"NCT03980717","Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH","A Prospective Study on the Role of Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension Among Fetuses With Severe Congenital Diaphragmatic Hernia","Inclusion Criteria:\n\n* Patient is a pregnant woman between 18 and 45 years of age\n* Singleton pregnancy\n* The fetuses will be 28+0\u002F7 to 31+6\u002F7 weeks of gestational age\n* Confirmed diagnosis of severe left- or right-sided CDH of the fetus: Observed\u002Fexpected total lung volume equal to or less than 0.32 with more than 21% of liver herniated into the hemithorax. (Ideally calculated between 28+0\u002F7 and 31+6\u002F7 weeks' gestation.)\n* Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not affect postnatal outcome\n* Normal fetal karyotype or microarray\n* The mother must be healthy enough to have surgery\n* Patient and father of the baby provide signed informed consent that details the maternal and fetal risks involved with the procedure\n* Patient willing to remain in Houston for the duration following balloon placement until delivery.\n\nExclusion Criteria:\n\n* Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia\n* Allergy to latex\n* Allergy or previous adverse reaction to a study medication specified in this protocol\n* Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy.\n* Fetal aneuploidy, known structural genomic variants, other major fetal anomalies that may impact the fetal\u002Fneonatal survival or known syndromic mutation\n* Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI\n* Maternal BMI \\>40\n* High risk for fetal hemophilia","FEMALE","18 Years","45 Years",{"count":103,"type":104},80,"ESTIMATED","INTERVENTIONAL",[107],"NA","Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax. In the more severe cases, the abdominal structures remain in the thoracic cavity and compromise the development of the lungs. Infants born with this defect have a decreased capacity for gas exchange; mortality rates after birth have been reported between 40-60%. Now that CDH can be accurately diagnosed by mid-gestation, a number of strategies have been developed to repair the hernia and promote lung tissue development.\n\nFetal tracheal occlusion (FETO), using a fetoscopically delivered and removed balloon device, has been used to temporarily occlude the trachea and increase lung distension in CDH to allow the lungs to develop and has been shown to increase survival at birth. The role of FETO in the resolution of pulmonary hypertension in fetuses with severe left- and right- sided CDH remains unclear. Our recent observation that FETO is associated with a higher proportion of infants who resolve their pulmonary hypertension by the age of 1 year as compared with those who have not had FETO, is based on a retrospective cohort study, which, as with any such design, has some intrinsic limitations. Thus, a prospective cohort study that is appropriately powered to confirm or disprove this encouraging observation is needed. If our preliminary observation is confirmed, resolution of PH by the age of 1 year could be added to the benefits of the FETO procedure in severe left and right-sided CDH cases.\n\nThe investigators will perform 40 FETO procedures on fetuses diagnosed prenatally with severe right- or left-sided CDH, and outcome data will be compared with that of a control group of severe right- or left-sided CDH who will not undergo the FETO procedure because of medical or social issues. Because the prevalence of left-sided CDH is higher than right-side CDH, the investigators will perform 25 FETO procedures in left sided CDH and 15 in right-sided CDH, and these outcomes will be compared to a cohort of 40 non FETO cases.",[110],"Congenital Diaphragmatic Hernia",[112,113,114,115,116,117],"Fetal Tracheal Occlusion","FETO plug-unplug","Goldvalve balloon","Severe Congenital Diaphragmatic Hernia","Goldbal balloon","FETO","2026-02-04",{"date":120,"type":121},"2026-02-06","ACTUAL",{"date":123,"type":121},"2019-08-09",{"date":125,"type":104},"2030-12",{"name":88,"class":6},1]