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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936322
Recruitment Status : Enrolling by invitation
First Posted : May 3, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Rodrigo Ruano M.D., Ph.D, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Spina Bifida Myelomeningocele Neural Tube Defects Device: Minimally invasive fetoscopic repair of MMC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spina Bifida

Arm Intervention/treatment
Experimental: Pregnant women diagnosed with fetal myelomeningocele
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
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.




Primary Outcome Measures :
  1. Maternal adverse events [ Time Frame: 5 years ]
    Total number of maternal adverse events

  2. Neonatal adverse events [ Time Frame: 5 years ]
    Total number of neonatal adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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

    1 (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.

Exclusion Criteria:

  • Exclusion Criteria

    • 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.
    • Amniotic Fluid Index (AFI) < 6 cm if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture. Low amniotic fluid volume that responds to maternal hydration is not an exclusion.
    • 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.
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936322


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Rodrigo Ruano, MD, PhD Mayo Clinic

Additional Information:
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Responsible Party: Rodrigo Ruano M.D., Ph.D, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03936322     History of Changes
Other Study ID Numbers: 18-008622
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Spinal Dysraphism
Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities