[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rodrigo Ruano\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100307401","fetal-cystoscopy-for-severe-lower-urinary-tract-obstruction-100307401",false,"NCT03281798","Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction","Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial","CYSTO","Inclusion Criteria:\n\n1. Pregnant women\n2. Singleton pregnancy\n3. Maternal age ≥ 18 years\n4. Male fetus with LUTO, dilated bladder, \"keyhole sign\" and bilateral hydronephrosis\n5. Oligohydramnios or Anhydramnios\n6. Favorable urine analysis defined as urinary sodium is \\\u003C 100 milliequivalents per liter (mEq\u002FL), chloride \\\u003C 90 mEq\u002FL, and osmolality \\\u003C 200 milliosmoles per kilogram (mOsm\u002Fkg) after 20 weeks and in the absence of previous in utero intervention for the disease (vesicoamniotic shunt placement or fetal cystoscopy).\n7. Absence of chromosomal abnormalities and associated anomalies\n8. Gestational age at the time of the procedure will be between 16 0\u002F7 weeks and 25 6\u002F7 weeks\n9. Normal karyotype by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). Patients declining invasive testing will be excluded.\n10. Family have considered and declined the option of termination of the pregnancy at less than 24 weeks.\n11. Family meets psychosocial criteria, including sufficient social support and ability to understand requirements of the study.\n12. Parents or guardian are willing to provide signed informed consent.\n\nExclusion Criteria:\n\n1. Fetal anomaly unrelated to LUTO\n2. Congenital cardiac anomaly\n3. Female fetus\n4. Increased risk for preterm labor including short cervical length (\\\u003C1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth\n5. Placental abnormalities (previa, abruption, accreta) known at time of enrollment\n6. Contraindications to surgery including previous hysterotomy in active uterine segment\n7. Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy\n8. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy\n9. 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\n10. Maternal medical condition that is a contraindication to surgery or anesthesia\n11. Patient does not have health insurance to cover routine clinical care including prenatal care, prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and fetal vesico-amniotic shunting. The exception will be fetal cystoscopy which is considered an experimental procedure.\n12. Inability to comply with travel and follow-up requirements of the trial\n13. Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy\n14. Patients declining invasive testing\n15. Family does not meet psychosocial criteria including insufficient","FEMALE","18 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe isolated lower urinary tract obstruction (LUTO).",[27,28,29,30],"Lower Urinary Tract Obstructive Syndrome","Lower Urinary Tract Obstruction, Congenital","Bladder Outlet Obstruction","Bladder Outflow Obstruction","RECRUITING","2026-02-20",{"date":34,"type":35},"2026-02-24","ACTUAL",{"date":37,"type":35},"2018-01-01",{"date":39,"type":21},"2028-08-01",{"name":41,"class":42},"Rodrigo Ruano","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":5},"100296428","fetal-endoscopic-tracheal-occlusion-for-congenital-diaphragmatic-hernia-feto-100296428","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","50 Years",{"count":20,"type":21},[24],"The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).",[56,57,58],"Congenital Diaphragmatic Hernia","Pulmonary Hypoplasia","Pulmonary Artery Hypertension",[60,61,62,63,64],"fetal lungs","fetal surgery","congenital diaphragmatic hernia","tracheal occlusion","pulmonary hypoplasia","2026-02-19",{"date":67,"type":35},"2026-02-23",{"date":69,"type":35},"2024-05-01",{"date":71,"type":21},"2030-11-01",{"name":41,"class":42},""]