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Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
N/A
Waitlist Available
Led By Rodrigo Ruano, MD, Ph.D.
Research Sponsored by Rodrigo Ruano
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Isolated Left CDH with liver up
Be between 18 and 65 years old
Must not have
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
History of incompetent cervix with or without cerclage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post partum
Awards & highlights
Summary
This trial is testing a new procedure to see if it is safe and effective.
Who is the study for?
This trial is for pregnant individuals with a single fetus diagnosed with severe left-sided Congenital Diaphragmatic Hernia (CDH) and liver up, without other fetal anomalies or chromosomal abnormalities. The fetus must have a specific lung-to-head ratio indicating pulmonary hypoplasia, and the gestational age should be between 27 to just under 32 weeks at the time of surgery.
What is being tested?
The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO), using BALT GoldbBAL2 Detachable Balloon and Catheter System. This procedure aims to improve lung development in fetuses with CDH by temporarily blocking their trachea.
What are the potential side effects?
Potential side effects are not explicitly listed but may include risks associated with any fetal surgery such as preterm labor, infection, or complications from the balloon catheter system used during FETO.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition involves the left side of my diaphragm being affected with my liver positioned higher.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a health condition that prevents me from having surgery during pregnancy.
Select...
I have had issues with my cervix opening too early during pregnancy.
Select...
I have a short cervix or conditions increasing my risk of early labor.
Select...
I do not have someone to stay with me during my pregnancy at the hospital.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months post partum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post partum
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency of unplanned balloon removal
Gestational Age at Delivery
Number of incidences of maternal complications
+3 moreSecondary study objectives
Fetal Lung Growth as measured via Fetal Lung Volume
Fetal Lung Growth as measured via LHR
Fetal survival
+10 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: FETO GroupExperimental Treatment2 Interventions
Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system.
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Who is running the clinical trial?
Rodrigo RuanoLead Sponsor
3 Previous Clinical Trials
29 Total Patients Enrolled
Rodrigo Ruano, MD, Ph.D.Principal InvestigatorUniversity of Miami
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have HIV, Hepatitis-B, or Hepatitis-C.My condition involves the left side of my diaphragm being affected with my liver positioned higher.My unborn baby has been diagnosed with additional anomalies or chromosomal abnormalities.My baby has a right-sided or bilateral diaphragmatic hernia, or an isolated left-sided one with specific ultrasound measurements.I have a health condition that prevents me from having surgery during pregnancy.My baby's genetic test results are normal.I have had issues with my cervix opening too early during pregnancy.You have a condition related to blood compatibility issues between a mother and her baby during pregnancy.You are pregnant with only one baby.If you are pregnant, your baby has severe underdevelopment of the lungs before 29 weeks and 6 days of pregnancy.You have had an allergic reaction to natural rubber latex in the past.I have a short cervix or conditions increasing my risk of early labor.The patient meets certain mental and social requirements.You are pregnant with more than one baby.I do not have someone to stay with me during my pregnancy at the hospital.You have placental abnormalities such as previa, abruption, or accrete when you join the study.If the baby's lung size is below a certain level at a certain stage of pregnancy, they may not be eligible.
Research Study Groups:
This trial has the following groups:- Group 1: FETO Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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