| ID | Type | Description | Link |
|---|---|---|---|
| 16-008720 | Other Identifier | Mayo Clinic |
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The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FETO Group | Experimental | Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BALT GoldbBAL2 Detachable Balloon | Device | Latex balloon, with radio-opaque inclusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of successfully completed FETO procedures | The number of successful placement and removal of balloon during FETO procedure | Up to 34 weeks gestation |
| Operative time | FETO placement and release operative times reported in minutes | Up to 34 weeks gestation |
| Frequency of unplanned balloon removal | The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal) | Up to 34 weeks gestation |
| Number of incidences of maternal complications | Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis | Up to 41 weeks gestation |
| Number of participants with maternal complications | Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis | Up to 41 weeks gestation |
| Gestational Age at Delivery | Gestation Age reported at time of delivery | Up to 41 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Lung Growth as measured via Fetal Lung Volume | Fetal Lung Volume as measured via ultrasound | Up to 41 weeks gestation |
| Fetal Lung Growth as measured via LHR | Lung area to head circumference Ratio (LHR) as measured via ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodrigo A Ruano, MD, Ph.D | Contact | 305.689.8001 | rodrigo.ruano@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Ruano, M.D., Ph.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D065630 | Hernias, Diaphragmatic, Congenital |
| D065627 | Familial Primary Pulmonary Hypertension |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
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| Catheter System |
| Device |
100 cm tapered micro-catheter |
|
|
| Up to 41 weeks gestation |
| Fetal survival | Fetal survival reported in days | Up to 24 months post partum |
| Number of newborns reported at each oxygen dependency grading | Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician | Up to 24 months post partum |
| Number of occurrence of severe pulmonary hypertension | Number of occurrence of severe pulmonary hypertension in infants as measured via echocardiogram | Up to 24 months post partum |
| Number of infants requiring ECMO Support | Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support | Up to 24 months post partum |
| Number of days in neonatal intensive care unit | Number of days infant was in the neonatal intensive care unit | Up to 24 months post partum |
| Number of days of ventilator support | Number of reported days infants required ventilator support | Up to 24 months post partum |
| Number of days of maternal hospitalization | Number of reported days of maternal hospitalization | Up to 24 months post partum |
| Number of infants reporting presence of complications | Number of infants reporting the presence of: periventricular leucomalacia at < 2 months postnatally, neonatal sepsis, intraventricular hemorrhage (grade 0-III), retinopathy of prematurity (grade III or higher), gastro-esophageal reflux, tracheomegaly and tracheomalacia | Up to 24 months post partum |
| Number of infants requiring the use of patch or muscle flap | Number of infants reported to require the use of patch or muscle flap | Up to 24 months post partum |
| Number of participants at each route of delivery | Number of participants that delivered vaginally and via caesarean section | Day 1 (post partum) |
| Number of days of Diaphragmatic Repair | Number of days of infant Diaphragmatic Repair | Up to 24 months post partum |
| Mayo Clinic | Terminated | Rochester | Minnesota | 55905 | United States |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |