Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-30 @ 2:57 PM
Study NCT ID:
NCT04356703
Status:
COMPLETED
Last Update Posted:
2020-04-22
First Post:
2020-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fetoscopic Open Spina Bifida Repair Using the SAFER Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016137', 'term': 'Spina Bifida Cystica'}, {'id': 'D008591', 'term': 'Meningomyelocele'}, {'id': 'D001139', 'term': 'Arnold-Chiari Malformation'}, {'id': 'D016135', 'term': 'Spinal Dysraphism'}, {'id': 'D005315', 'term': 'Fetal Diseases'}], 'ancestors': [{'id': 'D009436', 'term': 'Neural Tube Defects'}, {'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'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2020-04-20', 'studyFirstSubmitQcDate': '2020-04-20', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hydrocephalus treatment - shunt or ETV', 'timeFrame': '12 months corrected age or more', 'description': 'Need to treat hydrocephaly in the first year of life'}, {'measure': 'Ambulation', 'timeFrame': '30 months of cronological age or more', 'description': 'Ambulation Status'}, {'measure': 'Neurodevelopmental test', 'timeFrame': '30 months of cronogical age or more', 'description': 'PEDI scale will be performed'}], 'secondaryOutcomes': [{'measure': 'Anatomical verus motor level', 'timeFrame': '30 months of cronological age or more', 'description': 'To compare anatomical level with motor level'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myelomeningocele', 'spina bifida', 'meningomyelocele', 'fetal surgery', 'fetoscopy', 'fetal disease', 'fetal treatment'], 'conditions': ['Open Spina Bifida', 'Myelomeningocele', 'Meningomyelocele', 'Chiari Malformation With Spina Bifida', 'Chiari Malformation Type 2']}, 'referencesModule': {'references': [{'pmid': '31169957', 'type': 'BACKGROUND', 'citation': 'Sanz Cortes M, Lapa DA, Acacio GL, Belfort M, Carreras E, Maiz N, Peiro JL, Lim FY, Miller J, Baschat A, Sepulveda G, Davila I, Gielchinsky Y, Benifla M, Stirnemann J, Ville Y, Yamamoto M, Figueroa H, Simpson L, Nicolaides KH. Proceedings of the First Annual Meeting of the International Fetoscopic Myelomeningocele Repair Consortium. Ultrasound Obstet Gynecol. 2019 Jun;53(6):855-863. doi: 10.1002/uog.20308. No abstract available.'}, {'pmid': '29936963', 'type': 'BACKGROUND', 'citation': 'Lapa DA. Prenatal superior to postnatal myelomeningocele surgery. J Pediatr. 2018 Jul;198:322-325. doi: 10.1016/j.jpeds.2018.04.060. No abstract available.'}, {'pmid': '31350160', 'type': 'BACKGROUND', 'citation': 'Lapa DA. Endoscopic fetal surgery for neural tube defects. Best Pract Res Clin Obstet Gynaecol. 2019 Jul;58:133-141. doi: 10.1016/j.bpobgyn.2019.05.001. Epub 2019 Jun 29.'}, {'pmid': '31574466', 'type': 'BACKGROUND', 'citation': 'Carrabba G, Macchini F, Fabietti I, Schisano L, Meccariello G, Campanella R, Bertani G, Locatelli M, Boito S, Porro GA, Gabetta L, Picciolini O, Cinnante C, Triulzi F, Ciralli F, Mosca F, Lapa DA, Leva E, Rampini P, Persico N. Minimally invasive fetal surgery for myelomeningocele: preliminary report from a single center. Neurosurg Focus. 2019 Oct 1;47(4):E12. doi: 10.3171/2019.8.FOCUS19438.'}, {'pmid': '26386383', 'type': 'BACKGROUND', 'citation': 'Pedreira DA, Zanon N, Nishikuni K, Moreira de Sa RA, Acacio GL, Chmait RH, Kontopoulos EV, Quintero RA. Endoscopic surgery for the antenatal treatment of myelomeningocele: the CECAM trial. Am J Obstet Gynecol. 2016 Jan;214(1):111.e1-111.e11. doi: 10.1016/j.ajog.2015.09.065. Epub 2015 Sep 18.'}, {'pmid': '23386086', 'type': 'BACKGROUND', 'citation': 'Herrera SR, Leme RJ, Valente PR, Caldini EG, Saldiva PH, Pedreira DA. Comparison between two surgical techniques for prenatal correction of meningomyelocele in sheep. Einstein (Sao Paulo). 2012 Oct-Dec;10(4):455-61. doi: 10.1590/s1679-45082012000400011. English, Portuguese.'}, {'pmid': '21848412', 'type': 'BACKGROUND', 'citation': 'Pedreira DA, Quintero RA, Acacio GL, Caldini ET, Saldiva PH. Neoskin development in the fetus with the use of a three-layer graft: an animal model for in utero closure of large skin defects. J Matern Fetal Neonatal Med. 2011 Oct;24(10):1243-8. doi: 10.3109/14767058.2011.564486. Epub 2011 Aug 17.'}, {'pmid': '17546289', 'type': 'BACKGROUND', 'citation': 'Sanchez e Oliveira Rde C, Valente PR, Abou-Jamra RC, Araujo A, Saldiva PH, Pedreira DA. Biosynthetic cellulose induces the formation of a neoduramater following pre-natal correction of meningomyelocele in fetal sheep. Acta Cir Bras. 2007 May-Jun;22(3):174-81. doi: 10.1590/s0102-86502007000300004.'}]}, 'descriptionModule': {'briefSummary': 'Children submitted to fetoscopic in utero myelomeningocele repair using the SAFER (Skin-over-biocellulose for Anternatal FEtoscopic Repair) technique will evaluate at 30 months or more, regarding ambulation, neurodevelopment, urinary and fecal status.', 'detailedDescription': 'Children submitted to fetoscopic in utero myelomeningocele repair using the SAFER (Skin-over-biocellulose for Anternatal FEtoscopic Repair) technique will evaluate the neuropsicomotor development at 30 months of chronological age. The mental evaluation will use the Bayley III and thePEDI neurodevelopmental scale. The motor development will use the difference between anatomic and motor level of the lesion. Urinary and fecal continence will be evaluated using clinical and ultrasonographic parameters. For the anatomical level determination, immaging of the spine at the lesion level will be used. Motor level and ambulation will be evaluated through standard clinical examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '12 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children submitted to prenatal repair of open spina bifida using the fetoscopic percutaneous repair technique - SAFER', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren operated in utero using the SAFER technique\n\nExclusion Criteria:\n\nDeath before 30 month'}, 'identificationModule': {'nctId': 'NCT04356703', 'briefTitle': 'Fetoscopic Open Spina Bifida Repair Using the SAFER Technique', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Israelita Albert Einstein'}, 'officialTitle': 'Impact of Prenatal Correction of Spina Bifida Using Fetoscopy and the SAFER Technique on Long-term Neurodevelopment.', 'orgStudyIdInfo': {'id': 'HIAE-SAFER'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children submitted to fetoscopic surgery', 'description': 'Children submitted to fetoscopic in utero myelomeningocele repair using the SAFER (Skin-over-biocellulose for Anternatal FEtoscopic Repair) technique will evaluate the neuropsicomotor development at 30 months of chronological age or older', 'interventionNames': ['Other: Neuropsicomotor developmental test']}], 'interventions': [{'name': 'Neuropsicomotor developmental test', 'type': 'OTHER', 'description': 'Children will be evaluated trough Bayley III and PEDI scale. They also will be examined by pediatrician, neurosurgeon, orthopedics and phisiatry', 'armGroupLabels': ['Children submitted to fetoscopic surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Israelita Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'DENISE A LAPA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Israelita Albert Einstein'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Israelita Albert Einstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}