In-Utero Endoscopic Correction of Spina Bifida

NCT04362592 | Active Not Recruiting DMC FDA Device

• 1 other identifier: HS-05-00374
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the feasibility and effectiveness of performing fetoscopic surgical correction of fetal spina bifida. Two surgical approaches will be utilized: the percutaneous technique versus the laparotomy/uterine exteriorization technique.

Conditions

Neural Tube Defects; Spina Bifida; Myelomeningocele

Outcome Measures

Primary Outcomes (1)

• Ability to perform the endoscopic procedure

  Successful fetoscopic closure of the defect

  At time of surgery

Secondary Outcomes (1)

• Chiari II malformation reversal

  Prior to delivery

Study Arms (2)

Percutaneous Technique

EXPERIMENTAL

The percutaneous technique uses endoscopic scopes through the maternal skin and uterus to perform the surgery. A variation of the percutaneous technique is the mini-laparotomy technique, which uses an endoscopic scope through an incision on the abdomen, smaller than a laparotomy ("mini-laparotomy"), and smaller endoscopic scopes through the maternal skin and uterus to perform the surgery.

Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique

Laparotomy/Uterine Exteriorization Technique

EXPERIMENTAL

The laparotomy/uterine exteriorization technique consists of performing a laparotomy (incision into the abdominal cavity), exteriorizing the uterus, and using endoscopic scopes through the uterus to perform the correction.

Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique

Interventions

In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique DEVICE

The percutaneous approach uses endoscopes through a closed maternal abdomen and closed uterus to perform the spina bifida correction.

Percutaneous Technique

In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique DEVICE

The laparotomy/uterine exteriorization technique uses endoscopes through an open abdomen and closed, exteriorized uterus to perform the spina bifida correction.

Laparotomy/Uterine Exteriorization Technique

Eligibility Criteria

• Age: 18 Years - 52 Years
• Gender Eligibility Details: Gravid female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.
• Maternal age ≥18 years.
• Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.
• Balanced karyotype and/or normal mircoarray with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.
• Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study.
• Positive evaluation from pediatric neurology consult.
• Willing to return to our center, or to a multi-disciplinary spina bifida clinic closer to their home for the 6, 12, 24, 30, 48, and 60 months follow-up evaluations.

You may not qualify if:

• Multiple gestation
• Insulin-dependent pregestational diabetes
• Presence of a fetal anomaly not related to Chiari II Malformation. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.
• Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.
• Presence of uterine cervical cerclage or history of incompetent cervix.
• Placenta previa or placental abruption.
• Short cervix \< 25 mm measured by cervical ultrasound.
• Obesity as defined by body mass index (BMI) of 40 or greater.
• History of previous spontaneous singleton delivery prior to 37 weeks.
• Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia.
• Maternal HIV or Hepatitis-B status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to have negative results before she can be enrolled.
• Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened.
• Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality.
• Other maternal medical condition which is a contraindication to surgery or anesthesia.
• Patient does not have a support person (e.g., husband, partner, parents).

Sponsors & Collaborators

• University of Southern California: lead
• USFetus: collaborator

Study Sites (2)

Hollywood Presbyterian Medical Center

Los Angeles, California, 90027, United States

Location

Wellington Regional Medical Center

Wellington, Florida, 33141, United States

Location

MeSH Terms

Conditions

Neural Tube Defects; Spinal Dysraphism; Meningomyelocele

Condition Hierarchy (Ancestors)

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

Study Officials

• Ruben Quintero, MD

  US Fetus

  PRINCIPAL INVESTIGATOR

• Ramen Chmait, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: April 27, 2020
• Study Start: November 2, 2018
• Primary Completion: June 29, 2025
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (2)