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出境医 / 临床实验 / Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study

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

Study Description
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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
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 : June 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
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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.
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE May 1, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date January 27, 2021
Actual Study Start Date  ICMJE May 7, 2019
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • Maternal adverse events [ Time Frame: 5 years ]
    Total number of maternal adverse events
  • Neonatal adverse events [ Time Frame: 5 years ]
    Total number of neonatal adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study
Official Title  ICMJE Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spina Bifida
  • Myelomeningocele
  • Neural Tube Defects
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: Minimally invasive fetoscopic repair of MMC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 25, 2021) 		3
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2019) 		15
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03936322
Other Study ID Numbers  ICMJE 18-008622
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rodrigo Ruano M.D., Ph.D, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rodrigo Ruano, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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