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NCT03090633 · ClinicalTrials.gov registry record · NA
Fetoscopic Repair of Isolated Fetal Spina Bifida
A NA study of Spina Bifida and Myelomeningocele, sponsored by Johns Hopkins University.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03090633 is a NA study of Spina Bifida and Myelomeningocele that is active but no longer recruiting, run by Johns Hopkins University. The registered enrollment target is 30 participants, below the 51-participant average among 16 other Spina Bifida trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03090633, a NA study of Spina Bifida and Myelomeningocele, is active but no longer recruiting, sponsored by Johns Hopkins University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this investigation is to evaluate maternal and fetal outcomes following fetoscopic repair of fetal spina bifida at the Johns Hopkins Hospital. The hypothesis of this study is that fetoscopic spina bifida repair is feasible and has the same effectiveness as open repair of fetal spina bifida, but with the benefit of significantly lower maternal and fetal complication rates. The fetal benefit of the procedure will be the prenatal repair of spina bifida. The maternal benefit of fetoscopic spina bifida repair will be the avoidance of a large uterine incision. This type of incision increases the risk of uterine rupture and requires that all future deliveries are by cesarean section. The use of the minimally invasive fetoscopic surgical technique may also lower the risk of preterm premature rupture of membranes and preterm birth compared to open fetal surgery. Finally, successful fetoscopic spina bifida repair also makes vaginal delivery possible.
Conditions Studied
Interventions
- DEVICE Fetoscopy
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-05-11 |
| Est. Completion | 2027-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03090633
The ClinicalTrials.gov registry entry for NCT03090633 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 51-participant average among 16 other Spina Bifida trials with a reported enrollment target (41% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Spina Bifida appearing as the primary indexed condition, and to 1 intervention - of which Fetoscopy is the first listed.
NCT03090633 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03090633 about?
NCT03090633 is a clinical study titled "Fetoscopic Repair of Isolated Fetal Spina Bifida". The purpose of this investigation is to evaluate maternal and fetal outcomes following fetoscopic repair of fetal spina bifida at the Johns Hopkins Hospital. The hypothesis of this study is that fetoscopic spina bifida repair is feasible and has the same effectiveness as open repair of fetal spina ...
What is the current status of trial NCT03090633?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2017-05-11. Estimated completion is 2027-04.
What conditions does trial NCT03090633 study?
This clinical trial studies the following conditions: Spina Bifida, Myelomeningocele, Neural Tube Defects, Spinal Dysraphism, Chiari Malformation Type 2.
What interventions are being tested in trial NCT03090633?
The interventions under investigation include: Fetoscopy (DEVICE).
Who is sponsoring clinical trial NCT03090633?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03090633 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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