Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-02 @ 7:32 AM
Study NCT ID:
NCT04362592
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2020-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In-Utero Endoscopic Correction of Spina Bifida
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009436', 'term': 'Neural Tube Defects'}, {'id': 'D016135', 'term': 'Spinal Dysraphism'}, {'id': 'D008591', 'term': 'Meningomyelocele'}], 'ancestors': [{'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2031-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2020-03-24', 'studyFirstSubmitQcDate': '2020-04-22', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to perform the endoscopic procedure', 'timeFrame': 'At time of surgery', 'description': 'Successful fetoscopic closure of the defect'}], 'secondaryOutcomes': [{'measure': 'Chiari II malformation reversal', 'timeFrame': 'Prior to delivery', 'description': 'Reversal of hindbrain herniation on ultrasound and MRI'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Neural Tube Defects', 'Spina Bifida', 'Myelomeningocele']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '52 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Gravid female', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.\n2. Maternal age ≥18 years.\n3. Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.\n4. 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.\n5. 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.\n6. Positive evaluation from pediatric neurology consult.\n7. 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.\n\nExclusion Criteria:\n\n1. Multiple gestation\n2. Insulin-dependent pregestational diabetes\n3. Presence of a fetal anomaly not related to Chiari II Malformation. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.\n4. Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.\n5. Presence of uterine cervical cerclage or history of incompetent cervix.\n6. Placenta previa or placental abruption.\n7. Short cervix \\< 25 mm measured by cervical ultrasound.\n8. Obesity as defined by body mass index (BMI) of 40 or greater.\n9. History of previous spontaneous singleton delivery prior to 37 weeks.\n10. Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia.\n11. 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.\n12. Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened.\n13. Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality.\n14. Other maternal medical condition which is a contraindication to surgery or anesthesia.\n15. Patient does not have a support person (e.g., husband, partner, parents).\n16. Inability to comply with the travel and follow-up requirements of the study.\n17. Patient does not meet psychosocial criteria as determined by the social worker evaluation.\n18. Participation in another intervention study that influences maternal and fetal morbidity and mortality.\n19. 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).\n20. Bicornuate uterus or any other uterine malformation the PI decides is not safe for surgery.\n21. Nickel allergy.\n22. Maternal request to undergo open fetal surgery for the antenatal correction of OSB at our institution primarily or after failed fetoscopic approach.\n23. Known maternal hypersensitivity to bovine collagen or chondroitin materials."}, 'identificationModule': {'nctId': 'NCT04362592', 'briefTitle': 'In-Utero Endoscopic Correction of Spina Bifida', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'In-Utero Endoscopic Correction of Spina Bifida: Laparotomy-Assisted or Percutaneous', 'orgStudyIdInfo': {'id': 'HS-05-00374'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Percutaneous Technique', 'description': 'The percutaneous technique uses endoscopic scopes through the maternal skin and uterus to perform the surgery. A variation of the percutaneous technique is the mini-laparotomy technique, which uses an endoscopic scope through an incision on the abdomen, smaller than a laparotomy ("mini-laparotomy"), and smaller endoscopic scopes through the maternal skin and uterus to perform the surgery.', 'interventionNames': ['Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique']}, {'type': 'EXPERIMENTAL', 'label': 'Laparotomy/Uterine Exteriorization Technique', 'description': '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.', 'interventionNames': ['Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique']}], 'interventions': [{'name': 'In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique', 'type': 'DEVICE', 'description': 'The percutaneous approach uses endoscopes through a closed maternal abdomen and closed uterus to perform the spina bifida correction.', 'armGroupLabels': ['Percutaneous Technique']}, {'name': 'In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique', 'type': 'DEVICE', 'description': 'The laparotomy/uterine exteriorization technique uses endoscopes through an open abdomen and closed, exteriorized uterus to perform the spina bifida correction.', 'armGroupLabels': ['Laparotomy/Uterine Exteriorization Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ramen Chmait, MD', 'role': 'CONTACT', 'email': 'chmait@usc.edu', 'phone': '213-469-6277'}, {'name': 'Arlyn Llanes, RN', 'role': 'CONTACT', 'email': 'arlyn.llanes@med.usc.edu', 'phone': '213-469-6277'}], 'facility': 'Hollywood Presbyterian Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33141', 'city': 'Wellington', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ruben Quintero, MD', 'role': 'CONTACT', 'phone': '720-753-3825'}, {'name': 'Eftichia Kontopoulos, MD', 'role': 'CONTACT', 'phone': '720-753-3825'}], 'facility': 'Wellington Regional Medical Center', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}], 'centralContacts': [{'name': 'Ruben Quintero, MD', 'role': 'CONTACT', 'email': 'q@the-fetal-institute.com', 'phone': '720-753-3825'}, {'name': 'Ramen Chmait, MD', 'role': 'CONTACT', 'email': 'chmait@usc.edu', 'phone': '213-469-6277'}], 'overallOfficials': [{'name': 'Ruben Quintero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'US Fetus'}, {'name': 'Ramen Chmait, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'USFetus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ramen Chmait', 'investigatorAffiliation': 'University of Southern California'}}}}