Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Congenital Diaphragmatic Hernia (CDH)

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Dr Erin Perrone
Study ID
NCT07577414
Status
Recruiting
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Conditions

  • Congenital Diaphragmatic Hernia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) — DEVICE
    This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.

Study Details

The purpose of the study is to determine if babies with left or right-sided CDH that undergo the FETO procedure survive more often and have fewer long-term complications than babies that have similar left or right-sided CDH that elect not to have the FETO procedure performed during pregnancy.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FETO surgery Intervention Arm
    Eligible participants that choose the FETO Intervention Arm, will undergo two surgeries, one to place the balloon and a second to remove the balloon before delivery.
  • No Intervention: Expectant Management Arm
    Participants choose to undergo the expectant management, or routine care, of carrying a baby with Congenital Diaphragmatic Hernia (CDH). Participants will undergo a comprehensive fetal evaluation at Michigan Medicine's Fetal Diagnosis and Treatment Center (FDTC) to confirm the diagnosis and severity of the CDH. Eligibility will be based on the results of the clinical assessment.

Primary Outcome Measure

Compare neonatal survival to discharge in LCDH [ Time Frame: 6-12 months (birth to discharge) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Irene Carter
[email protected]
734-615-3883
Erin Perrone, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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