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NCT Number: NCT05672849

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Texas Childrens Hospital - Pavilion for Women

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Ahmed Nassr, M.D.

SUB_INVESTIGATOR

Alice King, M.D.

SUB_INVESTIGATOR

Becky Johnson

CONTACT

[email protected]

832-826-7451

Kwansoo Chun, PhD

SUB_INVESTIGATOR

Luc Joyeux, MD, PhD

SUB_INVESTIGATOR

Magdalena Sanz Cortes, M.D., PhD

SUB_INVESTIGATOR

Michael A Belfort, M.D.

PRINCIPAL_INVESTIGATOR

Michael A Belfort, MD

CONTACT

[email protected]

832-826-7375

Roopali Donepudi, MD

SUB_INVESTIGATOR

Sundeep Keswani, MD

SUB_INVESTIGATOR

Timothy Lee, M.D.

SUB_INVESTIGATOR

William Whitehead, MD, MPH

SUB_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Surgical Instruments/Devices (Sheaths and Irrigator)

Device

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.

Primary outcomes

  1. Number of adverse events

    Time frame: Immediate Post-Procedure period (until the leave the OR)

    Number of adverse events associated with the investigational device

  2. Number of device defects, malfunctions, or failures

    Time frame: Immediate Post-Procedure period (until the leave the OR)

    Number of device defects, malfunctions, or failures and whether the device performed as intended.

Study contacts

Contact information is provided by the study sponsor or research team.

Becky Johnson

CONTACT

[email protected]

832-826-7451

Michael A Belfort, MD

CONTACT

[email protected]

832-826-7375

Sponsors and collaborators

Lead sponsor

Michael A Belfort

Other

Collaborators

  • Baylor College of Medicine

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 5, 2023
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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