Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-31 @ 9:42 AM
Study NCT ID:
NCT00768703
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-03-27
First Post:
2008-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Endoscopic Tracheal Plug/Unplug for CDH (Congenital Diaphragmatic Hernia)
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Percutaneous Endoscopic Tracheal Plug/Unplug for Congenital Diaphragmatic Hernia
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Congenital diaphragmatic hernia is an anatomically simple birth defect in which contents of the fetal abdomen migrate into the chest due to incomplete formation of the diaphragm. Herniation of viscera into the chest prevents the fetal lungs from developing and growing to normal size. In the most severe cases, there is significant morbidity and mortality at birth. For these fetuses, fetal intervention may improve outcomes by enabling the lungs to grow enough in utero that they are capable of sustaining life after birth. This unblinded, non-randomized trial will assess the safety and efficacy of the use of the Goldvalve balloon and MiniTorquer microcatheter to perform percutaneous temporary tracheal occlusion to treat severe CDH in utero. The primary outcome variable will be fetal lung growth due to successful 'plugging/unplugging' of the trachea, as determined by serial lung-head ratio (LHR) measurements. Secondary outcome variables include maternal, fetal and neonatal variables, specifically neonatal survival at 90 days of life. For infants who survive beyond 90 days post-delivery, their families will be offered follow-up (up to 2 years of age and possibly beyond) in the Long-term Infant-to-Adult Follow-up Evaluation (LIFE) Clinic at UCSF.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TO CDH | OTHER | UCSF(University of California, San Francisco) Fetal Treatment Center | View |