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Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO Trial)
N/A
Recruiting
Led By Yair Blumenfeld, MD
Research Sponsored by Yair Blumenfeld
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 2 years
Awards & highlights
FETO Trial Summary
This trial will study the use of a balloon to block the trachea of a fetus with severe CDH, in order to see if this improves the chances of the baby's survival.
Who is the study for?
This trial is for pregnant women aged 18-50 with a single fetus diagnosed with severe congenital diaphragmatic hernia (CDH). They must stay near LPCH Stanford, plan to deliver there, and have normal genetic testing results. Excluded are those with latex allergies, certain CDH measurements, placental abnormalities, maternal infections like HIV or Hepatitis B/C, high risk of preterm labor/delivery, significant obesity (BMI >40), or involvement in another study affecting outcomes.Check my eligibility
What is being tested?
The FETO Goldballoon procedure by Balt medical is being tested for its effectiveness in treating severe CDH in fetuses. The balloon will be inserted endoscopically into the fetal trachea at LPCH Stanford which has specialized maternal-fetal medicine and neonatal services including ECMO and pediatric surgery.See study design
What are the potential side effects?
While specific side effects are not listed here, interventions like FETO may carry risks such as premature birth or complications from the surgical procedure itself. There could also be potential risks associated with anesthesia during the operation.
FETO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of neonates who survive until initial hospital discharge
Secondary outcome measures
Oxyhemoglobin
Number of children who survive until 1 year of age
Number of children who survive until 2 years of age
+2 moreFETO Trial Design
1Treatment groups
Experimental Treatment
Group I: Fetal Endoscopic Tracheal Occlusion (FETO)Experimental Treatment1 Intervention
FETO is performed in-utero and the balloon is removed prior to delivery, and children will have follow-up visits until the age of 2
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Who is running the clinical trial?
Yair BlumenfeldLead Sponsor
Yair Blumenfeld, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
200 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition involves a diaphragmatic hernia along with other structural anomalies.I do not have uncontrolled high blood pressure, diabetes, or other serious health issues.My BMI is over 40.My CDH type does not meet the study requirements.It's not possible or safe for me to have a balloon placed via fetoscopy.I have received counseling from various healthcare professionals.I have a uterine condition, like fibroids or a developmental abnormality.I am pregnant and have tested positive for HIV, Hepatitis B, or Hepatitis C.I am a woman aged between 18 and 50.I can stay within 30 minutes of LPCH Stanford during my treatment.I have a severe case of congenital diaphragmatic hernia.My baby's genetic tests from amniocentesis or CVS are normal.
Research Study Groups:
This trial has the following groups:- Group 1: Fetal Endoscopic Tracheal Occlusion (FETO)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment criteria for this trial restricted to individuals under twenty-five years of age?
"This trial seeks participants who are of legal age (18+) and below the half-century margin."
Answered by AI
Is it possible to join this medical research as a participant?
"Qualified individuals for this trial must have morgagni hernias and be between 18 and 50 years of age. Up to 15 participants are being accepted into the study."
Answered by AI
Are researchers still accepting participants for this experiment?
"Affirmative, according to the clinicaltrials.gov website this research is seeking volunteers with 15 patients being accepted at 1 medical site. This trial was initially posted on November 28th 2022 and its most recent update occurred a day later on November 29th 2022."
Answered by AI
How many individuals are currently participating in this research endeavor?
"Affirmative. It is apparent from the information posted on clinicaltrials.gov that this research study, which was initially advertised on November 28th 2022, remains actively recruiting. A total of 15 individuals are required to be recruited at a single clinical site."
Answered by AI
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