Fetoscopic Neural Tube Defect Repair

NCT06946563 | Recruiting DMC FDA Device

• 1 other identifier: OHSU IRB 24397
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm prospective study to record maternal and neonatal outcomes on subjects who undergo fetoscopic repair of Neural Tube Defects (NTD) at Oregon Health \& Science University (OHSU). Fetoscopic repair will take place between 24 weeks 0 days and 27 weeks 6 days gestation. Surgical, post-operative, delivery, and neonatal outcomes will be collected.

Conditions

Neural Tube Defects; Spina Bifida

Keywords

Fetal Surgery; Fetoscopy

Outcome Measures

Primary Outcomes (1)

• Feasibility of minimally invasive surgical repair of NTD in fetus

  Whether closure was achieved and whether the case was completed using the fetoscopic technique

  At the time of NTD repair surgery

Secondary Outcomes (1)

• Chiari II malformation reversal

  Post-surgery ultrasound (weekly from surgery to delivery), post-surgery fetal MRI (4-6 weeks after surgery), and postnatal MRI (5-7 days after birth)

Study Arms (1)

Fetoscopic Neural Tube Defect Repair

Individuals who undergo fetoscopic Neural Tube Defect (NTD) repair. Participants will undergo fetal surgery between 24 weeks 0 days and 27 weeks 6 days.

Device: Fetoscopic Neural Tube Defect Repair Devices

Interventions

Fetoscopic Neural Tube Defect Repair Devices DEVICE

Fetoscopic NTD repair will be performed on enrolled participants. An incision will be made to gain exposure and access to the uterus. The amniotic cavity is entered using a needle to administer fetal anesthesia. Then, the initial trocar is inserted into the amniotic cavity. The major steps of the procedure are neural placode dissection, myofascial flaps creation, and closure of the neural tube defect.

Also known as: Karl Storz Endoscopy-America, Inc., Richard Wolf Medical Instruments, Corp., Advanced Endoscopy Devices, Lexion Medical, LLC., Cook Medical, Inc., Becton Dickinson Visitec Pro, TERUMO Pinnacle, Integra LifeSciences, Applied Medical Resources

Fetoscopic Neural Tube Defect Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients with a diagnosed Neural Tube Defect (NTD) electing to undergo fetoscopic NTD repair.

You may qualify if:

• Maternal age 18 years or older
• Capable of consenting for their own participation in the study
• Decision to have fetoscopic repair following counseling of all options
• Open spina bifida with the upper boundary between T1 and S1
• Gestational age between 24 0/7 to 26 6/7 weeks' gestation at the time of surgery
• Normal karyotype and/or normal chromosomal microarray by invasive testing. In the case of a microdeletion, microduplication, or variant of uncertain significant, the decision to include or exclude will be at the discretion of the Principal Investigators.
• Absence of major cardiac anomalies confirmed by fetal echocardiogram
• Adequate social support throughout pregnancy
• Parental or guardian willingness to undergo follow-up evaluations of the child after birth

You may not qualify if:

• Multiple gestation
• Major fetal anomalies unrelated to the neural tube defect
• Kyphosis in fetus of 30 degrees or more as assessed by ultrasound or MRI
• Previous spontaneous singleton preterm birth prior to 37 weeks
• Presence of cervical cerclage at the time of surgery or history of cervical insufficiency
• Cervical length less than 20 mm by endovaginal ultrasound
• Placenta previa or evidence of placental abruption
• Technical factors such as large uterine fibroids, uterine anomalies, or fetal membrane separation for which the risks of surgery are deemed to outweigh the benefits
• Maternal obesity precluding surgical access with a BMI \> 45 or if the Principal Investigator determines the body habitus to be technically challenging
• Alloimmunization in pregnancy including Kell sensitization or a history of neonatal alloimmune thrombocytopenia
• Maternal HIV or Hepatitis B positive status. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to be negative prior to surgery
• Known Hepatitis C positivity. If the patient's Hepatitis C status is known, they do not need to be screened
• Maternal medical condition which is a contraindication to surgery or general anesthesia. This includes previous hysterotomy in the active segment of the uterus
• Maternal medical co-morbidities which would significantly increase the risk of spontaneous or iatrogenic preterm delivery
• Inability of the patient to comply with travel and follow-up requirements of the study

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Neural Tube Defects; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Raphael Sun, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Andrew Chon

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Women's Health Research Unit Department of Ob/Gyn

CONTACT

503-494-3666; whru@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 27, 2025
• Study Start: April 1, 2023
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2033
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)