At a glance
ClinicalIndex Comparison RecordN/ARecruiting· 25 target
Drug / intervention
Fetoscopic Endoluminal Tracheal Occlusion with the Smart-TO Balloonother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Non-invasive Removal of the Smart Tracheal Occlusion Device for Fetal Congenital Diaphragmatic Hernia: A Feasibility Study
In Brief
A clinical study evaluating Fetoscopic Endoluminal Tracheal Occlusion with the Smart-TO Balloon for Congenital Diaphragmatic Hernia. Currently recruiting, targeting 25 participants across 1 site.
Detailed Summary
The purpose of this study is to demonstrate the ability to prenatally deflate and to evaluate the safety of the Smart-TO device for fetoscopic endoluminal tracheal occlusion (FETO) in fetuses with congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Diaphragmatic Hernia
CountriesBelgium
Collaborators--
Timeline
N/ARecruiting
20222023202420252026
Enrollment StartSep 2021
First PostedOct 2021
TodayJul 2026
Primary CompletionAug 2026
Study CompletionNov 2026
First PostedOct 29, 2021
Enrollment StartSep 8, 2021
Primary CompletionAug 1, 2026
Study CompletionNov 1, 2026
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 4.7 years agoPrimary completion in 29 days
Interventions
Fetoscopic Endoluminal Tracheal Occlusion with the Smart-TO Balloonother
Fetal Endoscopic Tracheal Occlusion using the Smart-TO balloon and non-invasive balloon removal by the peripheral magnetic field of an magnetic resonance scanner.