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| Name | Class |
|---|---|
| Wellington Hospital | OTHER_GOV |
| University of Southern California | OTHER |
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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/uterine exteriorization approach will be offered to participants regardless of placental location.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fetoscopic repair | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fetoscopy | Device | Patients will receive fetoscopic repair of myelomeningocele. Patients with an anterior placenta will undergo the laparotomy with uterine exteriorization approach. Patients with a posterior placenta will undergo the percutaneous approach (or, if patient prefers, the laparotomy with uterine exteriorization approach). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful in-utero fetoscopic myelomeningocele closures using either laparotomy or percutaneous techniques | Successful fetoscopic closure of the spinal defect and reversal of hindbrain herniation as assessed by ultrasound and MRI prior to delivery | At time of surgery until delivery, up to 21 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruben Quintero, MD | Contact | 720-753-3825 | q@the-fetal-institute.com | |
| Ramen Chmait, MD | Contact | 626-356-3360 | chmait@usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ruben Quintero, MD | Wellington Regional Medical Center | Principal Investigator |
| Ramen Chmait, MD | University of Southern California/ Huntington Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California / Huntington Memorial Hospital | Recruiting | Los Angeles | California | 91105 | United States |
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| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D016135 | Spinal Dysraphism |
| D008591 | Meningomyelocele |
| D001139 | Arnold-Chiari Malformation |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D005332 | Fetoscopy |
| ID | Term |
|---|---|
| D011296 | Prenatal Diagnosis |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Wellington Regional Medical Center | Recruiting | Wellington | Florida | 33141 | United States |
|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D046128 | Fetal Therapies |
| D013812 | Therapeutics |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |