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

Not Applicable

Recruiting

• Conditions: Neural Tube Defects
• Interventions: Device: Modified Surgical Instruments/Devices (Sheaths and Irrigator)

• Registration Number: NCT05672849
• Lead Sponsor: Michael A Belfort

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).

Study Timeline

• Study Start: 2022-11-14
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modified Devices in fetoscopic NTD repair	Modified Surgical Instruments/Devices (Sheaths and Irrigator)	Single arm study. All patients will undergo fetoscopic NTD repair with the use of the modified devices.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Texas Childrens Hospital - Pavilion for Women; 🇺🇸 Houston, Texas, United States