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

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

Detailed Description
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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).

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

Conditions
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Neural Tube Defects

Intervention / Treatment
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* Device: Modified Surgical Instruments/Devices (Sheaths and Irrigator)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Devices in fetoscopic NTD repair<br>Single arm study. All patients will undergo fetoscopic NTD repair with the use of the modified devices. | Device: Modified Surgical Instruments/Devices (Sheaths and Irrigator)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | Number of adverse events associated with the investigational device | Immediate Post-Procedure period (until the leave the OR) | 
| Number of device defects, malfunctions, or failures | Number of device defects, malfunctions, or failures and whether the device performed as intended. | Immediate Post-Procedure period (until the leave the OR) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MMC, myelomeningocele, NTD, neural tube defect, spina bifida