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Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO Trial)
N/A
Waitlist Available
Led By Mauro Schenone, MD
Research Sponsored by Mauro H. Schenone
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 will study the safety and effectiveness of a procedure to help babies developing in the womb with severe lung problems. #medicine #CDH #FETO
Who is the study for?
This trial is for pregnant individuals with a fetus diagnosed with severe left-sided congenital diaphragmatic hernia (CDH) and poor lung development. Eligible participants must be able to give informed consent, have had appropriate counseling, carry a single pregnancy with normal fetal genetics, and be able to stay near the Mayo Clinic for the duration of the pregnancy.Check my eligibility
What is being tested?
The trial tests Fetoscopic Endoluminal Tracheal Occlusion (FETO), using specialized instruments like a fetoscope and detachable balloon to improve lung growth in fetuses with CDH. The procedure's safety and effectiveness are being studied at Mayo Clinic.See study design
What are the potential side effects?
Potential side effects may include complications from fetoscopic surgery such as preterm labor or damage to the uterus or fetus. There might also be risks associated with anesthesia and possible allergic reactions to latex used in some equipment.
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
ECMO Support
Fetal Lung Growth as measured via Fetal Lung Volume
Fetal Lung Growth as measured via LHR
+10 moreFETO Trial Design
1Treatment groups
Experimental Treatment
Group I: FETO GroupExperimental Treatment3 Interventions
Participants will undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure between 27 weeks 0 days and 29 weeks 6 days gestation.
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Who is running the clinical trial?
Mauro H. SchenoneLead Sponsor
1 Previous Clinical Trials
80 Total Patients Enrolled
Mauro Schenone, MDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
240 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- It's not safe or possible for me to have a balloon placed via fetoscopy.My unborn baby has a severe left-sided diaphragmatic hernia.My baby has underdeveloped lungs, confirmed by an ultrasound.I am less than 30 weeks pregnant.My baby has a diaphragmatic hernia on the right side, both sides, or isolated left with specific ultrasound findings.My baby's genetic tests are normal.I am positive for HIV, Hepatitis-B, or Hepatitis-C.My unborn baby has been diagnosed with serious health issues that could worsen their prognosis.I have a uterine condition that makes certain procedures difficult.My cervix is shorter than 20 mm or I have a uterine condition that could lead to early labor.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How might I become a participant in this research endeavor?
"This trial is searching for 20 individuals with congenital diaphragmatic hernia, aged between 18 and 50. Such patients can apply to be part of the study."
Answered by AI
Is this research project accepting participants aged forty or older?
"The age requirements for this medical trial are quite specific, with an 18 year lower limit and 50 the upper boundary."
Answered by AI
Is this research venture accessible to new participants?
"This trial, which was first published on July 1st 2023 and updated just 16 days later, is not currently enrolling any participants. Fortunately, there are 151 other experiments actively seeking volunteers at this time."
Answered by AI
What are the projected effects of this experiment?
"This clinical trial has a gestation period of up to 29 weeks and its primary objective is to assess the technical success of balloon retrieval. Secondary outcomes include use of patch or muscle flap, number of reported days for maternal hospitalization, and route of delivery (vaginal/caesarean section)."
Answered by AI
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