[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chiari-malformation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chiari-malformation":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100516952","development-of-a-patient-reported-outcome-measure-for-chiari-malformation-and-syringomyelia-100516952",false,"NCT06011226","Development of a Patient-reported Outcome Measure for Chiari Malformation and Syringomyelia","BCS-score","Inclusion Criteria:\n\nCriteria common to all subjects included in the study\n\n* Age \\> 18 years\n* Subject understanding French Patients included in Phase I\n* Subject with signed informed consent Patients included in phase II\n* Patient not opposed to study participation\n\nPatients Chiari only group:\n\n* Isolated descent of cerebellar tonsils \\> 5 mm below McRae's line (no associated syringomyelia)\n\nPatients syringomyelia only group:\n\n* Presence of an intramedullary fluid cavity secondary to circulatory disturbance of cerebrospinal fluid of non foraminal origin (no Chiari)\n\nPatients Chiari with Syringomyelia group:\n\n* Presence of Chiari malformation (tonsils \\> 5 mm below McRae's line) AND foraminal syringomyelia.\n\nExclusion Criteria:\n\n* Insufficient command of French\n* Minor or protected adult (guardianship, curatorship, safeguard of justice)\n* Diagnosis of Chiari and\u002For syringomyelia not proven by an MRI scan\n* Pregnant or breast-feeding","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","OBSERVATIONAL","Chiari malformation corresponds to the herniation of cerebellar tonsils into the foramen magnum resulting in obstruction of cerebrospinal fluid circulation, which may eventually lead to the formation of an intramedullary cavity called syringomyelia.\n\nChiari and syringomyelia can be responsible of variable symptoms, based on which neurosurgeons might propose surgical treatment. Yet, there is no properly developped and validated patient reported outcome measure (PROM) to assess the clinical severity of Chiari malformation and\u002For syringomyelia. The lack of such evaluation tool is a major issue to determine the optimal therapeutic strategy and to achieve a standardized and reproducible follow-up.",[24,25],"Syringomyelia","Chiari Malformation",[24,25,27],"patient-reported outcome measure","NOT_YET_RECRUITING","2023-09-18",{"date":31,"type":32},"2023-09-21","ACTUAL",{"date":34,"type":20},"2023-09",{"date":36,"type":20},"2026-12",{"name":38,"class":39},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":5},"100351453","laparotomy-versus-percutaneous-endoscopic-correction-of-myelomeningocele-100351453","NCT03856034","Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele","In Utero Endoscopic Correction of Myelomeningocele: Laparotomy Versus Percutaneous - A Pilot Study","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\u002F7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.\n4. Balanced karyotype 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 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 for the 12, 24, 30, 48, and 60 months for follow-up evaluation.\n\nExclusion Criteria:\n\n1. Multiple gestation\n2. Insulin-dependent pregestational diabetes\n3. 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.\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 \\\u003C 25 mm measured by cervical ultrasound.\n8. Obesity as defined by body mass index (BMI) of 35 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 open spina bifida at our institution primarily or after failed fetoscopic approach.\n23. Known maternal hypersensitivity to bovine collagen or chondroitin materials.","FEMALE",{"count":50,"type":20},12,"INTERVENTIONAL",[53],"NA","The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy\u002Futerine exteriorization approach will be offered to participants regardless of placental location.",[56,57,58,25],"Neural Tube Defects","Spina Bifida","Myelomeningocele",[60,61,62,63,64,65,66],"spina bifida","myelomeningocele","neural tube defect","chiari malformation","fetoscopy","percutaneous","fetus","RECRUITING","2019-11-11",{"date":70,"type":32},"2019-11-13",{"date":72,"type":32},"2018-11-02",{"date":74,"type":20},"2027-12-31",{"name":76,"class":39},"USFetus"]