Safety and Efficacy of FETO in CDH: A Phase III Trial

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Holly L Hedrick, MD
Study ID
NCT06884423
Status
Recruiting
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Conditions

  • Congenital Diaphragmatic Hernia
  • Pulmonary Hypoplasia

Eligibility Criteria

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

Interventions

  • FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter — DEVICE
    Fetoscopic Endoluminal Tracheal Occlusion (FETO) in CDH with GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter

Study Details

Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally. In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.

Key Dates

Start date
Apr 7, 2025
Status verified
Jul 2025
Primary completion
Apr 30, 2030
Completion
Apr 30, 2032

Study Design

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

Arms

  • Experimental: FETO in CDH
    Fetoscopic Endoluminal Tracheal Occlusion (FETO) will be performed by placing a detachable balloon inside the fetal airway and removing the balloon after several weeks. Devices: GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter. Assignment will be non-randomized. 40 maternal/fetal dyads will be enrolled in this arm.
  • No Intervention: Expectant Management in CDH
    The control arm includes patients eligible for FETO according to side of defect, O/E LHR, and liver position who undergo expectant management rather than FETO intervention. Assignment will be non-randomized. 40 maternal/fetal dyads will be enrolled in this arm.

Primary Outcome Measure

Successful placement and removal of the FETO Device [ Time Frame: 24 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Holly L Hedrick, MD, FACS
[email protected]
1-800-468-8376
Annaliese Aarthun
[email protected]
Holly L Hedrick (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-

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By research site
Children's Hospital of Philadelphia· Philadelphia, PA

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