Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study

NCT03794011 | Active Not Recruiting Phase 1 DMC FDA Device

• 1 other identifier: H-43359
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to compare the maternal, fetal and neonatal outcomes of a cohort of 60 patients in whom a multilayer closure with a Durepair patch is performed with a prior cohort of patients in whom a standardized repair without patch (n = 32) was performed using the same minimally invasive fetoscopic repair technique. The hypothesis is that there will be a thicker repair (as measured by MRI at 6 weeks post surgery) and less MMC repair dehiscence and/or CSF leak with the patch repair.

Conditions

Neural Tube Defects

Keywords

myelomeningocele; MMC; NTD; neural; defect; Spinal Bifida; Neural Tube Defect

Outcome Measures

Primary Outcomes (1)

• MMC Repair Dehiscence and/or CSF leak

  Rate of MMC repair dehiscence and/or CSF leak in each group

  at birth

Study Arms (1)

fetoscopic surgical repair

EXPERIMENTAL

Single arm study. All patients will receive the fetoscopic repair.

Device: fetoscopy

Interventions

fetoscopy DEVICE

The fetoscopic arm is described above. Patients who have an appropriate window (posterior placenta) and choose fetoscopic surgery will be offered the two fetoscopic options, (i) laparotomy assisted and, (ii) totally percutaneous expandable port assisted. Patients with an anterior placenta will only be offered the lapartotomy assisted approach. All patients will undergo a fetoscopic repair of the fetal open neural tube defect including a the use of a Durepair patch.

Also known as: Richard Wolf Medical Instruments, Corp., Karl Storz Endoscopy-America, Inc., Cook Medical, Inc., Lexion Medical, LLC., Terumo Pinnacle, Pare Surgical, Inc., Medtronic Neurosurgery, Canon Medical, Applied Medical

fetoscopic surgical repair

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women - maternal age 18 years or older and capable of consenting for their own participation in this study.
• Singleton pregnancy.
• MMC with the upper boundary located between T1 and S1.
• Evidence of hindbrain herniation (confirmed on MRI to have an Arnold-Chiari type II malformation). An exception will be made for patients unable to have an MRI due to implants or any medical reasons. These patients will have the Arnold-Chiari type II malformation reviewed by ultrasonography.
• Absence of chromosomal abnormalities and associated anomalies
• Gestational age at the time of the procedure will be between 19 0/7 weeks and 25 6/7 weeks.
• Normal karyotype and/or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). If there is a balanced translocation with normal CMA with no other anomalies the candidate can be included. Patients declining invasive testing will be excluded. Results by flouorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.
• The family has considered and declined the option of termination of the pregnancy at less than 24 weeks.
• The family meets psychosocial criteria (sufficient social support, ability to understand the requirements of the study).
• Parental/guardian permission (informed consent) for follow up of the child after birth.

You may not qualify if:

• Fetal anomaly unrelated to MMC.
• Severe kyphosis.
• Increased risk for preterm labor including short cervical length (\<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth.
• Placental abnormalities (previa, abruption, accreta) known at time of enrollment.
• A pre-pregnancy body-mass index ≥40.
• Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment.
• Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, or uterine anomalies.
• Maternal-fetal Rh alloimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
• Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patients HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment.
• Maternal medical condition that is a contraindication to surgery or anesthesia.
• Patient does not have a support person (i.e. Spouse, partner, mother) available to support the patient for the duration of the pregnancy.
• Inability to comply with the travel and follow-up requirements of the trial.
• Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.
• Patient scores as severely depressed on the Edinburgh Postnatal Depression Scale
• Maternal hypersensitivity to collagen.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (2)

Stanford University: Lucille Packard's Children's Hospital

Stanford, California, 94305, United States

Location

Texas Childrens Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Corroenne R, Mehollin-Ray AR, Johnson RM, Whitehead WE, Espinoza J, Castillo J, Castillo H, Orman G, Donepudi R, Huisman TAGM, Nassr AA, Belfort MA, Sanz Cortes M, Shamshirsaz AA. Impact of the volume of the myelomeningocele sac on imaging, prenatal neurosurgery and motor outcomes: a retrospective cohort study. Sci Rep. 2021 Jun 23;11(1):13189. doi: 10.1038/s41598-021-92739-2.

  PMID: 34162982 DERIVED

MeSH Terms

Conditions

Neural Tube Defects; Meningomyelocele

Interventions

Fetoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Fetal Therapies; Therapeutics; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures

Study Officials

• Michael A. Belfort, M.D., Ph.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 4, 2019
• Study Start: December 18, 2018
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (2)