Evaluating devices for repairing neural tube defects in fetoscopic procedures
Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases
This study is testing new tools to see if they make it safer and easier to fix neural tube defects in unborn babies during a special type of surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05672849 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of specialized devices used during fetoscopic neural tube defect repair procedures at Texas Children's Fetal Center. Patients who choose to undergo this repair will be invited to participate, where they will receive detailed information about the study and have the opportunity to discuss their participation. The fetoscopic procedure involves a series of surgical steps to repair the defect, utilizing modified surgical instruments and devices. The study will follow a structured informed consent process to ensure participants are fully aware of their involvement.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have opted for fetoscopic neural tube defect repair.
Not a fit: Patients who do not choose to undergo fetoscopic neural tube defect repair will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and effectiveness of surgical interventions for neural tube defects, potentially leading to better outcomes for affected infants.
How similar studies have performed: Previous studies involving similar fetoscopic techniques have shown promising results, indicating that this approach is both tested and potentially effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who elect to undergo fetoscopic neural tube defect repair Exclusion Criteria: * Patients who do not elect to undergo fetoscopic neural tube defect repair
Where this trial is running
Houston, Texas
- Texas Childrens Hospital - Pavilion for Women — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Michael A Belfort, MD — Baylor College of Medicine and Texas Children's Hospital
- Study coordinator: Michael A Belfort, MD
- Email: belfort@bcm.edu
- Phone: 832-826-7375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.