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NCT02230072 · ClinicalTrials.gov registry record · Phase 1
Fetoscopic Meningomyelocele Repair Study
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT02230072 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 60 participants.
The verdict
NCT02230072, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the maternal and fetal outcomes of a new technique for the fetoscopic repair of fetal MMC at Texas Children's Hospital Pavilion for Women. The investigators hypothesis is that this minimally invasive technique is feasible, and that this approach will have the same efficacy as open fetal surgery for MMC, but with significantly less maternal-fetal risk. Both mother and baby will benefit from the surgery. The fetus will have a repaired MMC defect, and the mother will not have a uterine incision (hysterotomy). A hysterotomy increases the risk of uterine rupture and requires that all subsequent deliveries are by cesarean section. There may also be a decreased risk of Pre-term Premature Rupture Of Membranes (PPROM) and prematurity when compared with the current open operation. Finally, a vaginal delivery is possible following the fetoscopic fetal surgery if the baby is shown to have a skin covered repair.
Interventions
- DEVICE fetoscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-07-29 |
| Est. Completion | 2025-06-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02230072
The ClinicalTrials.gov registry entry for NCT02230072 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which fetoscopy is the first listed.
NCT02230072 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02230072 about?
NCT02230072 is a clinical study titled "Fetoscopic Meningomyelocele Repair Study". The purpose of the study is to evaluate the maternal and fetal outcomes of a new technique for the fetoscopic repair of fetal MMC at Texas Children's Hospital Pavilion for Women. The investigators hypothesis is that this minimally invasive technique is feasible, and that this approach will have the...
What is the current status of trial NCT02230072?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2014-07-29. Estimated completion is 2025-06-23.
What interventions are being tested in trial NCT02230072?
The interventions under investigation include: fetoscopy (DEVICE).
Who is sponsoring clinical trial NCT02230072?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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