Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases
Michael A Belfort
Summary
The purpose of the study is to evaluate the safety and efficacy of devices used in patients undergoing fetoscopic neural tube defect repair.
Description
All patients who choose to undergo fetoscopic neural tube defect repair at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Patients who elect to undergo fetoscopic neural tube defect repair Exclusion Criteria: * Patients who do not elect to undergo fetoscopic neural tube defect repair
Interventions
- DeviceModified Surgical Instruments/Devices (Sheaths and Irrigator)
Patients who choose to undergo fetoscopic surgery will be offered participation in this study. All patients will undergo a fetoscopic repair of the fetal open neural tube defect with the use of the modified devices in this study.
Location
- Texas Childrens Hospital - Pavilion for WomenHouston, Texas