Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)

Part of paid clinical trials in New York, New York.

Sponsor
Vincent Duron
Study ID
NCT05354505
Status
Recruiting
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Conditions

  • Diaphragmatic Hernia

Eligibility Criteria

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

Interventions

  • Placement of the GOLDBAL2 balloon — DEVICE
    The Fetal Endoscopic Tracheal Occlusion (FETO) procedure using the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) will be used to treat fetuses diagnosed with severe Congenital Diaphragmatic Hernia (CDH)

Study Details

This is a single site, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University Irving Medical Center (CUIMC)/ NewYork-Presbyterian Hospital (NYP).

Key Dates

First listed
Apr 29, 2022
Start date
May 28, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    GOLDBAL2 balloon will be placed for Fetus diagnosed with Congenital diaphragmatic hernia (CDH) at Gestational age of 27w0d - 29w6d and retrieved at Gestational age of 34w0d to 34w 6 days

Primary Outcome Measure

Total number of subjects with successful placement of the balloon [ Time Frame: Up to 30 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center/NewYork-PresbyterianNew YorkNew York10032
Amanda Alonso, MHA
[email protected]
212-342-0261
Vincent Duron, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center/NewYork-Presbyterian· New York, NY