Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT02390895
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2015-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prenatal Endoscopic Repair of Fetal Spina Bifida
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008591', 'term': 'Meningomyelocele'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2015-02-15', 'studyFirstSubmitQcDate': '2015-03-11', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful surgery', 'timeFrame': 'Before 26 gestational weeks', 'description': 'Composite criteria:\n\n1. dissection of the placode\n2. primary coverage or use of a patch\n3. using only endoscopy with two trocars'}, {'measure': 'Neonatal surgery', 'timeFrame': 'Day 0 (birth of neonates)', 'description': 'Need for neonatal surgery'}, {'measure': 'Arnold Chiari anomaly at birth', 'timeFrame': 'Day 0 (birth of neonates)', 'description': 'the existence of an Arnold Chiari anomaly at birth'}, {'measure': 'Ventriculo-peritoneal shunt', 'timeFrame': 'Within the 6 months after birth', 'description': 'Ventriculo-peritoneal shunt within the 6 months after birth'}, {'measure': 'Level of injury', 'timeFrame': 'Within the 6 months after birth'}, {'measure': 'Foetal morbidity', 'timeFrame': 'From surgery to delivery', 'description': 'Composite criteria:\n\nStillbirth; Premature Rupture of Membranes; Preterm birth; Chorioamnionitis; Hemorrhagic complications during the peri-operative period; Other serious adverse events'}, {'measure': 'Motor lower limb improvement outcomes', 'timeFrame': 'Within the 6 months after birth'}, {'measure': 'Maternal morbidity', 'timeFrame': 'From surgery to delivery', 'description': 'Composite criteria:\n\nStillbirth; Premature Rupture of Membranes; Preterm birth; Chorioamnionitis; Hemorrhagic complications during the peri-operative period; Other serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Neurological development', 'timeFrame': 'Within the 12 months after birth', 'description': 'Composite criteria:\n\nMotor deficit medullary reflex orthopedic anomalies consequences on perinea and sphincter'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Minimally-invasive endoscopic repair', 'fetal surgery', 'outcome', 'Foetus'], 'conditions': ['Myelomeningocele']}, 'referencesModule': {'references': [{'pmid': '36044834', 'type': 'BACKGROUND', 'citation': 'Arthuis C, James S, Bussieres L, Hovhannisyan S, Corroenne R, Ville Y, Stirnemann JJ. Laparotomy-Assisted 2-Port Fetoscopic Repair of Spina Bifida Aperta: Report of a Single-Center Experience in Paris, France. Fetal Diagn Ther. 2022;49(9-10):377-384. doi: 10.1159/000525552. Epub 2022 Aug 31.'}, {'pmid': '24891102', 'type': 'BACKGROUND', 'citation': 'Kohl T. Percutaneous minimally invasive fetoscopic surgery for spina bifida aperta. Part I: surgical technique and perioperative outcome. Ultrasound Obstet Gynecol. 2014 Nov;44(5):515-24. doi: 10.1002/uog.13430.'}, {'pmid': '21306277', 'type': 'BACKGROUND', 'citation': "Adzick NS, Thom EA, Spong CY, Brock JW 3rd, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Dabrowiak ME, Sutton LN, Gupta N, Tulipan NB, D'Alton ME, Farmer DL; MOMS Investigators. A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med. 2011 Mar 17;364(11):993-1004. doi: 10.1056/NEJMoa1014379. Epub 2011 Feb 9."}, {'pmid': '24753062', 'type': 'BACKGROUND', 'citation': 'Degenhardt J, Schurg R, Winarno A, Oehmke F, Khaleeva A, Kawecki A, Enzensberger C, Tinneberg HR, Faas D, Ehrhardt H, Axt-Fliedner R, Kohl T. Percutaneous minimal-access fetoscopic surgery for spina bifida aperta. Part II: maternal management and outcome. Ultrasound Obstet Gynecol. 2014 Nov;44(5):525-31. doi: 10.1002/uog.13389.'}, {'pmid': '22126123', 'type': 'BACKGROUND', 'citation': 'Verbeek RJ, Heep A, Maurits NM, Cremer R, Hoving EW, Brouwer OF, van der Hoeven JH, Sival DA. Fetal endoscopic myelomeningocele closure preserves segmental neurological function. Dev Med Child Neurol. 2012 Jan;54(1):15-22. doi: 10.1111/j.1469-8749.2011.04148.x. Epub 2011 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the feasibility of prenatal minimally-invasive fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation ii) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch', 'detailedDescription': 'Compared with an open approach involving laparotomy and hysterotomy, an endoscopic approach for the prenatal surgery of myelomeningocele offers at least two potential advantages: i) it may reduce the maternal and obstetric morbidity related to the hysterotomy; ii) it may be performed earlier in gestation than open surgery, therefore potentially further reducing exposition of the spinal chord to the intraamniotic environment and thus improving the overall prognosis of the malformation. This study aims to evaluate the feasibility and potential benefits of a minimally invasive endoscopic procedure for the prenatal treatment of myelomeningocele in a single-center trial.\n\nTechnically the procedure will be performed through 2 intra-amniotic ports, under fetoscopic visualization and intra-amniotic carbon dioxide insufflation. The defect will be dissected and the cord replaced in the canal. Closure will be performed by suturing paravertebral muscles using a barbed running suture. A Duragen patch will be sutured when primary closure is deemed impossible.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient \\> 18 years old, with an assumption by health insurance, understanding and speaking French\n* A term \\< or = 26 +0 weeks gestational age\n* Single-Pregnancy\n* Myelomeningocele with higher-level defect between S1 and T1\n* Arnold Chiari anomaly\n* No associated anomaly or chromosic anomaly\n\nExclusion Criteria:\n\n* severe foetal kyphoscoliosis associated\n* Increased risk of preterm birth: cervical length \\<15 mm, history of at least 2 late miscarriages, existing premature rupture of membrane\n* placenta previa, accreta or placental abruption\n* Maternal obesity with BMI\\> 35\n* Uterine anomalies : large interstitial uterine fibroid, uterine malformation\n* maternal infection with a foetal transmission risk: HIV, HBV, HCV\n* Maternal contradiction in surgery or anesthesia\n* poor social status and/or social isolation\n* impossible post-surgery follow-up\n* want to have a medical pregnancy termination'}, 'identificationModule': {'nctId': 'NCT02390895', 'acronym': 'ENDOSPIN', 'briefTitle': 'Prenatal Endoscopic Repair of Fetal Spina Bifida', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Prenatal Endoscopic Repair of Fetal Spina Bifida', 'orgStudyIdInfo': {'id': 'P141202'}, 'secondaryIdInfos': [{'id': '2014-A01948-39', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minimally-invasive endoscopic repair', 'description': 'endoscopic repair of myelomeningocele before 26 SA', 'interventionNames': ['Procedure: endoscopic repair of myelomeningocele before 26 SA']}], 'interventions': [{'name': 'endoscopic repair of myelomeningocele before 26 SA', 'type': 'PROCEDURE', 'description': 'prenatal minimally-invasive fetoscopic closure with iii) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation iv) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch', 'armGroupLabels': ['Minimally-invasive endoscopic repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Yves Ville, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Julien Stirnemann, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}