Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study

NCT03936322 | Completed Results DMC FDA Device

• 1 other identifier: 18-008622
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are studying a new minimally invasive technique (fetoscopic repair) for repair of spina bifida (MMC) during the second trimester of pregnancy. Researchers are trying to determine if this less invasive surgical approach will have less risk to the mother and at the same time adequate closure of the fetal spina bifida defect.

Conditions

Spina Bifida; Myelomeningocele; Neural Tube Defects

Outcome Measures

Primary Outcomes (2)

• Maternal Adverse Events

  Total number of maternal adverse events

  From time of surgery until delivery (up to 21 weeks)

• Neonatal Adverse Events

  Total number of neonatal adverse events

  From the time of surgery until 28 days of life (up 25 weeks)

Study Arms (1)

Pregnant women diagnosed with fetal myelomeningocele

EXPERIMENTAL

Women subjects who are pregnant and diagnosed with myelomeningocele (MMC), also known as fetal spina bifida or neural tube defect, will undergo a minimally invasive fetoscopic repair of MMC.

Device: Minimally invasive fetoscopic repair of MMC

Interventions

Minimally invasive fetoscopic repair of MMC DEVICE

Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy.

Pregnant women diagnosed with fetal myelomeningocele

Eligibility Criteria

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

You may qualify if:

• Pregnant women - maternal age 18 years or older
• Gestational age at the time of the procedure between 19 0/7 weeks and 25 6/7 weeks
• Singleton pregnancy.
• MMC diagnosis with the upper boundary located between Thoracic 1 (T1) and Sacral
• (S1).
• Evidence of hindbrain herniation (confirmed on MRI to have an Arnold-Chiari type II malformation).
• Absence of chromosomal abnormalities and associated anomalies.
• Normal karyotype and/or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or CVS). If there is a balanced translocation with normal CMA with no other anomalies the candidate can be included.
• Family has considered and declined the option of termination of the pregnancy at less than 24 weeks.
• Family meets psychosocial criteria (sufficient social support, ability to understand requirements for this study).
• Pregnant subject capable of consenting for their own participation in this study.
• Willingness to undergo an open MMC repair, if necessary
• Parental/guardian permission (informed consent) for follow up of child after birth.

You may not qualify if:

• Fetal anomaly unrelated to MMC.
• Multiple gestation
• Declined invasive testing for karyotype (amniocentesis or CVS)
• Severe kyphosis (defined as curvature of the spina (vertebras) higher than 30o degree measured by ultrasonography or magnetic resonance imaging).
• Increased risk for preterm labor including short cervical length (\<2.0 cm), history of incompetent cervix with or without cerclage, and previous preterm birth.
• Placental abnormalities (previa, abruption, accreta) known at time of enrollment.
• A body-mass index ≥40 at first prenatal visit.
• 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, uterine anomalies incompatible with fetoscopy.
• Maternal-fetal Rh isoimmunization, 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.
• A score of ≥ 29 on the Beck Depression Inventory (BDI) at screening
• Maternal hypersensitivity to collagen
• Patient does not have a support person (i.e. Spouse, partner, mother) available to support the patient for the duration of the pregnancy.

Sponsors & Collaborators

• Rodrigo Ruano: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Spinal Dysraphism; Meningomyelocele; Neural Tube Defects

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Rodrigo Ruano MD PhD
• Organization: UNIVERSITY OF MIAMI

rodrigoruano@hotmail.com

(305) 585-5610

Study Officials

• Rodrigo Ruano, M.D., Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Regulatory Sponsor

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: May 7, 2019
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)