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Procedure

FETO for Congenital Diaphragmatic Hernia (FETO Trial)

N/A
Waitlist Available
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR <25% with liver up
No pathogenic variants on microarray or pathologic findings on karyotype
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (before balloon placement), immediately prior to balloon retrieval
Awards & highlights

FETO Trial Summary

This trial is to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at UC Davis Medical Center.

Who is the study for?
This trial is for pregnant women over 18 with a single pregnancy and severe Congenital Diaphragmatic Hernia (CDH) in the fetus. Participants must live within 30 minutes of UC Davis Medical Center, have no major fetal cardiac defects or additional abnormalities, and agree to lifestyle restrictions including not working or engaging in exercise and intercourse.Check my eligibility
What is being tested?
The study tests Fetal Endoscopic Tracheal Occlusion using GOLDBAL2 balloon and BALTACCI-BDPE100 microcatheter on fetuses with CDH. The procedure occurs between 27-29 weeks' gestation, with removal around week 34, monitored by UC Davis Medical Center.See study design
What are the potential side effects?
Potential side effects may include complications from the fetoscopic surgery such as preterm labor or damage to the uterus or fetus. There might also be risks associated with living under restricted conditions affecting mental well-being.

FETO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My unborn baby has severe lung issues due to CDH, with a very low lung-to-head ratio.
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My genetic tests did not show any harmful changes.
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I am pregnant and 18 years or older.

FETO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~27 weeks 0 days to 29 weeks 6 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 weeks 0 days to 29 weeks 6 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of successful placements of the Goldballoon Detachable Balloon (GOLDBAL2) at gestational age 27 weeks zero days (27w0d) to 29 weeks and 6 days (29w6d) gestation.
Number of successful retrievals of the GOLDBAL2
Secondary outcome measures
Change in fetal lung growth
Change in observed to expected total fetal lung to head ratios (o/e TFLV) on prenatal magnetic resonance imaging (MRI)
Gestational age at delivery
+2 more

FETO Trial Design

1Treatment groups
Experimental Treatment
Group I: FETO with GOLDBAL2Experimental Treatment1 Intervention
A balloon will be placed in the airway of the fetus during the FETO procedure.

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,573 Total Patients Enrolled

Media Library

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05421676 — N/A
Congenital Diaphragmatic Hernia Research Study Groups: FETO with GOLDBAL2
Congenital Diaphragmatic Hernia Clinical Trial 2023: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) Highlights & Side Effects. Trial Name: NCT05421676 — N/A
FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05421676 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an open enrollment period for this research endeavor?

"As of now, this investigation is not looking to add any new participants. Originally posted on September 1st and last edited on June 13th, it is currently inactive; however, there are 161 other trials that accept enrollees at the moment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Fetal Endoscopic Tracheal Occlusion for CDH (CDH)
Shinjiro Hirose, MD 2024. "Fetal Endoscopic Tracheal Occlusion for CDH (CDH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05421676.
All > Hernia
~7 spots leftby Dec 2027
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