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New treatment option for Congenital Diaphragmatic Hernia
Official title Fetal Endoscopic Tracheal Occlusion for CDH (CDH)
ClinicalTrials.gov ID: NCT05421676
What this study is testing
- What it's testing
- This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at UC Davis Medical Center. The study will enroll pregnant women that meet study criteria.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
- Pregnant women, age 18 years and older
- Singleton pregnancy
- No pathogenic variants on microarray or pathologic findings on karyotype
You likely can't join if
- Adults unable to consent
- Prisoners
- Multi-fetal pregnancy
- History of latex allergy
- History of preterm labor or incompetent cervix (requiring cerclage), short cervix (\<20mm), or uterine anomaly predisposing to preterm labor
- Psychosocial ineligibility
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
- Pregnant women, age 18 years and older
- Singleton pregnancy
- No pathogenic variants on microarray or pathologic findings on karyotype
- Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
- Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR \<25% with liver up
- Gestational age at FETO procedure: if o/e LHR \<25% will be done at 27 weeks plus 0 days to 29 weeks plus 6 days
- Meets psychosocial criteria
- Willing to reside within 30 minutes of UC Davis Medical Center and ability to maintain follow up appointments
- Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near the UC Davis Medical Center.
- Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work
- Adults unable to consent
- Prisoners
- Multi-fetal pregnancy
- History of latex allergy
- History of preterm labor or incompetent cervix (requiring cerclage), short cervix (\<20mm), or uterine anomaly predisposing to preterm labor
- Psychosocial ineligibility
- Inability to reside within 30 minutes of UC Davis Medical Center or inability to maintain follow up appointments
- Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude her as a potential candidate.
- Bilateral CDH, unilateral CDH with o/e LHR \> 25% or unilateral CDH with o/e LHR \<25% but liver completely down in abdomen
- Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
- Maternal contraindications to elective fetoscopic surgery
- Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
- Maternal isoimmunization or neonatal alloimmune thrombocytopenia
- 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
- Sacramento, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, 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.