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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05672849
• Other study ID #: H-51509
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: December 2027

Study information

• Verified date: December 2023
• Source: Baylor College of Medicine
• Contact: Michael A Belfort, MD
• Phone: 832-826-7375
• Email: belfort[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neural Tube Defects
• Spinal Dysraphism

Intervention

Device:
• Modified 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.

Locations

Country	Name	City	State
United States	Texas Childrens Hospital - Pavilion for Women	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Michael A Belfort	Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events	Number of adverse events associated with the investigational device	Immediate Post-Procedure period (until the leave the OR)
Primary	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)