Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia

Part of paid clinical trials in Stanford, California.

Sponsor
Yair Blumenfeld
Study ID
NCT05461222
Status
Recruiting
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Conditions

  • Congenital Diaphragmatic Hernia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Balt "Goldballoon" — DEVICE
    Fetal endoscopic tracheal occlusion (FETO) is a procedure where a balloon is placed in the main airway or "windpipe" of the fetus, to help with the development of the lungs. This is performed using a fetoscope, a small camera that is inserted into the amniotic cavity and deploying the FETO Goldballoon into the fetal trachea.

Study Details

The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into the fetal trachea), manufactured by Balt medical. The investigators hope to study the risks and benefits of FETO in cases of severe CDH in an advanced medical center such as Lucile Packard Children's Hospital (LPCH) Stanford with access to advanced maternal-fetal medicine, neonatal services, and neonatal ECMO, and pediatric surgery.

Key Dates

Start date
Apr 17, 2023
Status verified
Jan 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2030

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Fetal Endoscopic Tracheal Occlusion (FETO)
    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

Primary Outcome Measure

Number of neonates who survive until initial hospital discharge [ Time Frame: Average approximately 6 months (up to 1 year) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lucile Packard Children's HospitalStanfordCalifornia94305-6070
Kathryn Batham
[email protected]
6507247826

Find similar trials in Stanford, CA

By research site
Lucile Packard Children's Hospital· Stanford, CA

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