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Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO Trial)
N/A
Recruiting
Led By Rodrigo Ruano, M.D., Ph.D.
Research Sponsored by Rodrigo Ruano M.D., Ph.D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post partum
Awards & highlights
FETO Trial Summary
This trial is testing a new medical 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 maternal health risks. The gestational age must be between 27 weeks and 31 weeks 6 days at the time of the FETO procedure, depending on specific lung-to-head ratio measurements.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of Fetoscopic Endoluminal Tracheal Occlusion (FETO), using BALT GoldbBAL2 Detachable Balloon and Catheter System to treat CDH in fetuses by occluding the trachea to promote lung growth.See study design
What are the potential side effects?
Potential side effects may include complications from fetoscopic surgery such as preterm labor, membrane rupture, or infection. There could also be risks associated with anesthesia during the procedure.
FETO Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of unplanned balloon removal
Gestational Age at Delivery
Number of incidences of maternal complications
+3 moreSecondary outcome measures
Fetal Lung Growth as measured via Fetal Lung Volume
Fetal Lung Growth as measured via LHR
Fetal survival
+10 moreFETO Trial 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 Ruano M.D., Ph.DLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Rodrigo RuanoLead Sponsor
3 Previous Clinical Trials
29 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
10 Patients Enrolled for Pulmonary Arterial Hypertension
Rodrigo Ruano, M.D., Ph.D.Principal InvestigatorUniversity of Miami
1 Previous Clinical Trials
10 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have HIV, Hepatitis-B, or Hepatitis-C.I am at risk of early labor due to a short cervix or uterine issues.I do not have someone to stay with me during my pregnancy at the hospital.I have had a weak cervix, with or without a stitch.You have a condition that can affect your pregnancy called maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia.You have a specific type of congenital diaphragmatic hernia (CDH) that affects the right side or both sides, or a left-sided CDH with certain ultrasound measurements.Any additional birth defects or genetic abnormalities found during prenatal testing will mean you cannot participate.I have a health condition that prevents me from having surgery during pregnancy.My baby's genetic test results are normal.You are pregnant with only one baby.If the baby's lung size is less than 25% of what is expected at 27 to 29 weeks of pregnancy, or between 25% and 30% of what is expected at 30 to 31 weeks of pregnancy, based on the mother's last menstrual period and the first ultrasound, they will not be included.You are pregnant with more than one baby.The patient meets mental and emotional well-being requirements.If the baby's lungs are too small based on ultrasound measurements taken before they are 29 weeks old, they will not be able to participate in the study. If the lungs are a little small based on ultrasound measurements taken between 30 to 31 weeks, the baby will not be able to participate in the study.You have had an allergic reaction to latex.You have placental abnormalities known when you join the study.My condition involves a left-sided diaphragmatic hernia with the liver positioned higher than normal.
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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