Clinical trial NCT05672849: Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases
Official title: Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neural Tube Defects
Keywords: myelomeningocele
MMC
NTD
neural tube defect
spina bifida
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
First posted: 2023-01-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse events
timeFrame: Immediate Post-Procedure period (until the leave the OR)
measure: Number of device defects, malfunctions, or failures
timeFrame: Immediate Post-Procedure period (until the leave the OR)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Childrens Hospital - Pavilion for Women
state: Texas
Study officials:
affiliation: Baylor College of Medicine and Texas Children's Hospital
name: Michael A Belfort, MD
role: PRINCIPAL_INVESTIGATOR
References: