Fetoscopic Endoluminal Tracheal Occlusion
Recruiting
N/A
Interventional Study
Hernia, DIaphragmatic, Congenital
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Device Feasibility
- Participants needed
- 10 (estimated)
- Sponsor
- Children's Hospitals and Clinics of Minnesota · Other
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About This Trial
This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Midwest Fetal Care Center, a collaboration between Allina Health and Children's Minnesota. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. A subject is defined as a female (18 years or older) who is pregnant.
2. The pregnancy must be a singleton pregnancy.
3. The CDH must be left-sided.
4. The CDH must be severe (Observed to Expected Lung to Head Ratio - O/E LHR - \< 25% from U/S measurements).
5. No associated …
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