Fetoscopic NEOX Cord 1K® Spina Bifida Repair

NAActive, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 28, 2020

Primary Completion Date

May 30, 2023

Study Completion Date

March 12, 2029

Conditions
Spina BifidaMyelomeningoceleMyeloschisis
Interventions
DEVICE

NEOX Cord 1K

Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (HUC) will be used for skin closure at the discretion of the neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.

Trial Locations (1)

77030

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
lead

The University of Texas Health Science Center, Houston

OTHER