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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 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.

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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.

Conditions Studied

Neural Tube Defects

Interventions

  • DEVICE fetoscopy

Study Locations (2)

California

  • Stanford University: Lucille Packard's Children's Hospital - Stanford

Texas

  • Texas Childrens Hospital - Houston

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2018-12-18
Est. Completion 2026-08
Phase Phase 1

Sponsor

Baylor College of Medicine

616 total trials

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What the Registry Record Tells You About NCT03794011

The ClinicalTrials.gov registry entry for NCT03794011 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55-participant average among 5 other Neural Tube Defects trials with a reported enrollment target (31% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.