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New treatment option for Congenital Diaphragmatic Hernia
Official title Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
ClinicalTrials.gov ID: NCT05461222
What this study is testing
- What it's testing
- The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into the fetal trachea), manufactured by Balt medical.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- Maternal Age: 18-50
- Singleton gestation
- Gestational age before 29 weeks 6 days
- Severe left or right-sided CDH: For severe left sided CDH observed-to-expected lung-to- head ratio (o/e LHR) less than 25% between 22 and 29 6/7...
- Normal genetic karyotype or microarray testing by amniocentesis or chorionic villus sampling (CVS)
You likely can't join if
- Contraindications to fetal surgery including poorly controlled hypertension, diabetes or other maternal medical condition including hematological...
- High risk for preterm labor and/or delivery based on either significant history of preterm birth, short cervix (measuring \< 20mm), significant...
- Non-isolated CDH - CDH with additional structural anomalies
- Significant maternal obesity defined as a body mass index (BMI) greater than 40. BMI is a calculation which includes a person's height and weight
- History of natural rubber latex allergy
- Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
See the full eligibility criteria
- Maternal Age: 18-50
- Singleton gestation
- Gestational age before 29 weeks 6 days
- Severe left or right-sided CDH: For severe left sided CDH observed-to-expected lung-to- head ratio (o/e LHR) less than 25% between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30%...
- Normal genetic karyotype or microarray testing by amniocentesis or chorionic villus sampling (CVS)
- Absence of associated fetal structural cardiac anomalies by a dedicated fetal echocardiogram
- Absence of other structural anomalies by ultrasound or MRI
- Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT).
- Must be willing to remain near LPCH Stanford (within 30 minutes from the hospital) for the duration of the balloon placement.
- No maternal and/or fetal contra-indications to fetal surgery such as a bleeding disorder, poorly controlled diabetes or hypertension, short cervix (measuring \< 20mm), risk for preterm birth etc.
- Planned pregnancy surveillance at LPCH Stanford
- Planned delivery at LPCH Stanford
- Able to provide written consent
- Willingness to comply with all study procedures and availability (meets psychosocial criteria) for the duration of the study including having a support person
- Contraindications to fetal surgery including poorly controlled hypertension, diabetes or other maternal medical condition including hematological disorder
- High risk for preterm labor and/or delivery based on either significant history of preterm birth, short cervix (measuring \< 20mm), significant uterine anomaly or other risk factor, incompetent cervix (requiring...
- Non-isolated CDH - CDH with additional structural anomalies
- Significant maternal obesity defined as a body mass index (BMI) greater than 40. BMI is a calculation which includes a person's height and weight
- History of natural rubber latex allergy
- Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
- Participation in another intervention study that influences maternal and fetal morbidity and mortality.
- Bilateral CDH, left-sided CDH with O/E LHR \>25%, or left-sided CDH with O/E LHR \<25% but liver completely down in abdomen
- Right-sided CDH O/E LHR \>30% or right-sided CDH with O/E LHR \<30% with liver completely down in abdomen
- Significant placental abnormalities (abruption, chorioangioma, accreta) known at the time of enrollment and/or surgery
- Maternal-fetal Rhesus isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia, affecting the current pregnancy.
- Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure
- No safe or feasible fetoscopic approach to balloon placement.
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.