Fetoscopic Neural Tube Defect Repair (NTD)

Fetoscopic Neural Tube Defect Repair: Observational Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Neural Tube Defects; Spina Bifida
• Intervention / Treatment: Device: Fetoscopic Neural Tube Defect Repair Devices

Detailed Description

Patients undergoing fetoscopic NTD repair will be enrolled. Possible surgical approaches include completely percutaneous, laparotomy assisted, or mini laparotomy. Surgical approach will be determined by placental location, maternal body habitus, and shared decision making with the patient. The actual fetoscopic NTD repair is the same regardless of the surgical approach. Follow-up data collection will occur post-operatively, at delivery, NICU admission, and throughout childhood.

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Women's Health Research Unit Department of OB/Gyn; Phone Number: 503-494-3666; Email: whru@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Women's Health Research Unit; Phone Number: 503-494-3666; Email: whru@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Patient not meeting psychosocial criteria determined by fetal care social worked to comply with the medical care and plan for follow ups
• Participation in another interventional study that influences maternal and fetal morbidity and mortality
• Known history of hypersensitivity to collagen products or chondroitin materials

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chiari II malformation reversal	Reversal of hindbrain herniation based on ultrasound, fetal MRI, and postnatal MRI	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)

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Raphael Sun, MD, Oregon Health and Science University; Principal Investigator: Andrew Chon, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2033

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: April 20, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Fetoscopy; Fetal Surgery
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Spinal Dysraphism; Neural Tube Defects
• Other Study ID Numbers: OHSU IRB 24397

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No