CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 5 enrolled
Drug / intervention
GoldBal2 detachable balloon +2 moredevice
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.

Search/NCT02875860
NCT02875860Phase 2Completed
CompareCT.gov

TOTAL TRIAL: Randomized Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) Versus Expectant Management During Pregnancy in Fetuses With Left-Sided and Isolated Congenital Diaphragmatic Hernia and Moderate Pulmonary Hypoplasia

Michael A Belfort·interventional·Posted Aug 23, 2016·Updated Jun 23, 2022

In Brief

A Phase 2 clinical trial evaluating GoldBal2 detachable balloon, Baltaccidbpe100 Delivery Catheter, and 1 other intervention for Hernia and 8 related conditions. Completed, enrolled 5 participants across 1 site.

Detailed Summary

This trial will test whether temporary fetoscopic endoluminal tracheal occlusion (FETO) rather than expectant management during pregnancy, followed by standardized postnatal management, increases survival at discharge and decreases oxygen need at 6 months in case of survival till discharge.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHernia, Hernia, Diaphragmatic, Hernia, DIaphragmatic, Congenital, Pathological Conditions, Anatomical, Congenital Abnormalities, Congenital Diaphragmatic Hernia, Fetal Anomaly, Fetal Surgery, Pulmonary Hypoplasia
CountriesUnited States
CollaboratorsBaylor College of Medicine, Universitaire Ziekenhuizen KU Leuven

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 23, 2016
Enrollment StartJan 1, 2017
Primary CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.9 years ago

Interventions

GoldBal2 detachable balloondevice

Placement of the balloon using the plug/unplug method.

Baltaccidbpe100 Delivery Catheterdevice

The catheter assists with implanting the balloon in the plug/unplug method.

Standardized postnatal careother

After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622