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Procedure

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
No Placebo-Only Group

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post partum
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post partum for reporting.

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 more
Secondary study objectives
ECMO Support
Fetal Lung Growth as measured via Fetal Lung Volume
Fetal Lung Growth as measured via LHR
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Media Library

Fetal Endoscopic Tracheal Occlusion (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05962346 — N/A
Congenital Diaphragmatic Hernia Research Study Groups: FETO Group
Congenital Diaphragmatic Hernia Clinical Trial 2023: Fetal Endoscopic Tracheal Occlusion Highlights & Side Effects. Trial Name: NCT05962346 — N/A
Fetal Endoscopic Tracheal Occlusion (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05962346 — N/A
~13 spots leftby Jul 2043
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