Neural Tube Defects
Conditions
Keywords
myelomeningocele, MMC, NTD, neural tube defect, spina bifida
Brief summary
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
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).
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.
Sponsors
Baylor College of Medicine
Michael A Belfort
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | Immediate Post-Procedure period (until the leave the OR) | Number of adverse events associated with the investigational device |
| Number of device defects, malfunctions, or failures | Immediate Post-Procedure period (until the leave the OR) | Number of device defects, malfunctions, or failures and whether the device performed as intended. |
Countries
United States
Contacts
Primary ContactMichael A Belfort, MD
Backup ContactBecky Johnson
Outcome results
None listed