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In-Utero Endoscopic Correction of Spina Bifida

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04362592
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ramen Chmait, University of Southern California

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.

Condition or disease Intervention/treatment Phase
Neural Tube Defects Spina Bifida Myelomeningocele Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In-Utero Endoscopic Correction of Spina Bifida: Laparotomy or Percutaneous
Actual Study Start Date : November 2, 2018
Estimated Primary Completion Date : November 2, 2022
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Percutaneous Technique
The percutaneous technique uses endoscopic scopes through the maternal skin and uterus to perform the surgery.
Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique
The percutaneous approach uses endoscopes through a closed maternal abdomen and closed uterus to perform the spina bifida correction.

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




Primary Outcome Measures :
  1. Ability to perform the endoscopic procedure [ Time Frame: At time of surgery ]
    Successful fetoscopic closure of the defect


Secondary Outcome Measures :
  1. Chiari II malformation reversal [ Time Frame: Prior to delivery ]
    Reversal of hindbrain herniation on ultrasound and MRI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gravid female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.
  2. Maternal age ≥18 years.
  3. Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.
  4. 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.
  5. 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.
  6. Positive evaluation from pediatric neurology consult.
  7. Willing to remain in the greater Wellington or Pasadena area (within a 30-minute car ride) for remainder of the pregnancy and deliver at Wellington Regional Medical Center or Huntington Memorial Hospital for postnatal management. The participants must be 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.

Exclusion Criteria:

  1. Multiple gestation
  2. Insulin-dependent pregestational diabetes
  3. Presence of a fetal anomaly not related to myelomeningocele. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.
  4. Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.
  5. Presence of uterine cervical cerclage or history of incompetent cervix.
  6. Placenta previa or placental abruption.
  7. Short cervix < 25 mm measured by cervical ultrasound.
  8. Obesity as defined by body mass index (BMI) of 35 or greater.
  9. History of previous spontaneous singleton delivery prior to 37 weeks.
  10. Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia.
  11. 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.
  12. Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened.
  13. Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality.
  14. Other maternal medical condition which is a contraindication to surgery or anesthesia.
  15. Patient does not have a support person (e.g., husband, partner, parents).
  16. Inability to comply with the travel and follow-up requirements of the study.
  17. Patient does not meet psychosocial criteria as determined by the social worker evaluation.
  18. Participation in another intervention study that influences maternal and fetal morbidity and mortality.
  19. Maternal hypertension as determined by the investigator, which would increase the risk of preeclampsia or preterm delivery (including, but not limited to: uncontrolled hypertension, chronic hypertension with end organ damage and new onset hypertension in current pregnancy).
  20. Bicornuate uterus or any other uterine malformation the PI decides is not safe for surgery.
  21. Nickel allergy.
  22. Maternal request to undergo open fetal surgery for the antenatal correction of OSB at our institution primarily or after failed fetoscopic approach.
  23. Known maternal hypersensitivity to bovine collagen or chondroitin materials.

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): NCT04362592


Contacts
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Contact: Ruben Quintero, MD 720-753-3825 q@the-fetal-institute.com

Locations
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United States, California
Huntington Hospital Recruiting
Pasadena, California, United States, 91105
Contact: Ramen Chmait, MD    626-356-3360    chmait@usc.edu   
Contact: Arlyn Llanes, RN    626-356-3360    arlyn.llanes@med.usc.edu   
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Ruben Quintero, MD US Fetus
Principal Investigator: Ramen Chmait, MD University of Southern California
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Responsible Party: Ramen Chmait, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT04362592    
Other Study ID Numbers: HS-05-00374
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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