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NCT03794011 · ClinicalTrials.gov registry record · Phase 1
Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study
A Phase 1 study of Neural Tube Defects, sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 2
- Study locations
NCT03794011: Active Phase 1 study of Neural Tube Defects, sponsored by Baylor College of Medicine.
NCT03794011 is a Phase 1 study of Neural Tube Defects that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 38 participants, below the 55-participant average among 5 other Neural Tube Defects trials with a reported enrollment target (31% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03794011, a Phase 1 study of Neural Tube Defects, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of the study is to compare the maternal, fetal and neonatal outcomes of a cohort of 60 patients in whom a multilayer closure with a Durepair patch is performed with a prior cohort of patients in whom a standardized repair without patch (n = 32) was performed using the same minimally invasive fetoscopic repair technique. The hypothesis is that there will be a thicker repair (as measured by MRI at 6 weeks post surgery) and less MMC repair dehiscence and/or CSF leak with the patch repair.
Primary Outcome
Rate of MMC repair dehiscence and/or CSF leak in each group
Conditions Studied
Interventions
- DEVICE fetoscopy
Study Locations (2)
California
- Stanford University: Lucille Packard's Children's Hospital - Stanford
Texas
- Texas Childrens Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2018-12-18 |
| Est. Completion | 2026-08 |
| Phase | Phase 1 |
What the registry record for NCT03794011 still lists
NCT03794011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 55-participant average among 5 other Neural Tube Defects trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Neural Tube Defects appearing as the primary indexed condition, and to 1 intervention - of which fetoscopy is the first listed.
NCT03794011 reports a single indexed study location in California, Texas.
Frequently Asked Questions
What is clinical trial NCT03794011 about?
NCT03794011 is a clinical study titled "Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study". The purpose of the study is to compare the maternal, fetal and neonatal outcomes of a cohort of 60 patients in whom a multilayer closure with a Durepair patch is performed with a prior cohort of patients in whom a standardized repair without patch (n = 32) was performed using the same minimally inva...
What is the current status of trial NCT03794011?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2018-12-18. Estimated completion is 2026-08.
What conditions does trial NCT03794011 study?
This clinical trial studies the following conditions: Neural Tube Defects.
What interventions are being tested in trial NCT03794011?
The interventions under investigation include: fetoscopy (DEVICE).
Who is sponsoring clinical trial NCT03794011?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03794011 being conducted?
This trial has 2 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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