Clinical Trials Logo

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy of devices used in patients undergoing fetoscopic neural tube defect repair.


Clinical Trial Description

All patients who choose to undergo fetoscopic neural tube defect repair at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate in the study, informed consent will be obtained, and patients provided a copy of the signed consent. Fetoscopic Procedure: The fetoscopic open neural tube defect repair procedure will be performed with the same technique in this protocol as the investigators did in the previous protocols under this IDE (NCT02230072 and NCT03794011) in terms of exteriorization of the uterus, preparation for the fetoscopic repair and repair of the open neural tube defect. This involves release of the placode, dissection of the surrounding skin, development of myofascial flaps on either side of the defect, placement of a patch to be laid on top of the placode prior to closure of the myofascial flaps, suture of the flaps over the freed placode and patch and attempted primary closure of the defect using available skin. If necessary, the surgeons will use relaxing incisions or a skin patch to provide additional mobility to the skin to be closed over the defect. If the surgeons are unable to close the skin primarily despite best fetoscopic efforts, the option of performing/completing the repair as an open procedure exists and will be offered to the subject. Follow-Up: The investigators will follow patients for the immediate post-procedure period (until they leave the OR). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05672849
Study type Interventional
Source Baylor College of Medicine
Contact Michael A Belfort, MD
Phone 832-826-7375
Email belfort@bcm.edu
Status Recruiting
Phase N/A
Start date November 14, 2022
Completion date December 2027

See also
  Status Clinical Trial Phase
Completed NCT05883761 - Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment
Terminated NCT04140669 - Automated Myocardial Performance Index Using Samsung HERA W10
Completed NCT01244399 - Influence of "Espresso" on Adsorption of Myo-inositol
Recruiting NCT03856034 - Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele N/A
Recruiting NCT04362592 - In-Utero Endoscopic Correction of Spina Bifida N/A
Active, not recruiting NCT03936322 - Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study N/A
Completed NCT01743196 - Folate Metabolism in Normal Weight and Obese Women of Child-bearing Age N/A
Active, not recruiting NCT03090633 - Fetoscopic Repair of Isolated Fetal Spina Bifida N/A
Completed NCT01392989 - Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders Phase 2
Completed NCT06174883 - Salt-FA to Increase Folate Levels
Completed NCT05935631 - Feasibility, Acceptability and Directional Signal Effect on Blood Folate Levels of Iodized Salt Fortified With Folic Acid: Clinical Study N/A
Recruiting NCT03315637 - Fetal Endoscopic Surgery for Spina Bifida N/A
Completed NCT00394862 - Efficacy of Weekly Versus Daily Folic Acid Supplementation N/A
Completed NCT04135274 - Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Neural Tube Defects?
Completed NCT06135883 - Assessing Folic Acid in High-Risk Pregnancy for Neural Tube Defects
Active, not recruiting NCT04760509 - Short- Term Follow up Of Neonates Born With Neural Tube Defect
Active, not recruiting NCT03794011 - Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study Phase 1
Recruiting NCT04523233 - Metals/Vitamins Levels in NTD
Recruiting NCT01253746 - Genetics of Neural Tube Defects N/A
Completed NCT00468481 - Efficacy and Safety Study for an Oral Contraceptive Containing Folate Phase 3