Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases

Neural Tube Defects Clinical Trial

Official title: Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases

Status Recruiting

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy of devices used in patients undergoing fetoscopic neural tube defect repair.

Clinical Trial 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 in the study, informed consent will be obtained, and patients provided a copy of the signed consent.

Fetoscopic Procedure: The fetoscopic open neural tube defect repair procedure will be performed with the same technique in this protocol as the investigators did in the previous protocols under this IDE (NCT02230072 and NCT03794011) in terms of exteriorization of the uterus, preparation for the fetoscopic repair and repair of the open neural tube defect. This involves release of the placode, dissection of the surrounding skin, development of myofascial flaps on either side of the defect, placement of a patch to be laid on top of the placode prior to closure of the myofascial flaps, suture of the flaps over the freed placode and patch and attempted primary closure of the defect using available skin. If necessary, the surgeons will use relaxing incisions or a skin patch to provide additional mobility to the skin to be closed over the defect. If the surgeons are unable to close the skin primarily despite best fetoscopic efforts, the option of performing/completing the repair as an open procedure exists and will be offered to the subject.

Follow-Up: The investigators will follow patients for the immediate post-procedure period (until they leave the OR). ;

Related Conditions & MeSH terms

• Neural Tube Defects
• Spinal Dysraphism

• NCT number: NCT05672849
• Study type: Interventional
• Source: Baylor College of Medicine
• Contact: Michael A Belfort, MD
• Phone: 832-826-7375
• Email: belfort@bcm.edu
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Completion date: December 2027