Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe CDH
Part of paid clinical trials in New York, New York.
- Sponsor
- NYU Langone Health
- Study ID
- NCT07767825
- Status
- Not Yet Recruiting
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Conditions
- Severe Congenital Diaphragmatic Hernia
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Goldballoon Detachable Balloon (GOLDBAL2) — DEVICEGOLDBAL2 will be inserted into the fetal trachea and deployed with the Delivery Microcatheter (BALTACCI-BDPE100).
Study Details
The purpose of this pilot study is to evaluate the feasibility of using Fetoscopic Endoluminal Tracheal Occlusion (FETO) in 10 pregnant individuals carrying fetuses with severe congenital diaphragmatic hernia (CDH). FETO surgery will be performed at 27 weeks - 29 weeks and 6 days of gestation, and the fetoscopic removal of the balloon will be performed at 34 weeks - 34 weeks and 6 days of gestation. The primary endpoint is successful placement and removal of the balloon.
Key Dates
- First listed
- Aug 17, 2026
- Start date
- Sep 30, 2026
- Status verified
- Aug 2026
- Primary completion
- Sep 30, 2029
- Completion
- Sep 30, 2031
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Congenital diaphragmatic hernia (CDH)FETO surgery will be performed at 27 weeks - 29 weeks and 6 days of gestation, and the fetoscopic removal of the balloon will be performed at 34 weeks - 34weeks and 6 days of gestation.
Primary Outcome Measure
Number of successful balloon placements at age 27w0d - 29w6d and removal at 34 weeks of gestation [ Time Frame: Up to 35 weeks ]
Central Contacts
- Erin Lonergan, MHA, BSN, RN212-814-4261
- Jose L. Peiro, MD, PhD212-263-7391
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | - |