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NCT04243889 · ClinicalTrials.gov registry record · NA

Fetoscopic NEOX Cord 1K® Spina Bifida Repair

A NA study of Spina Bifida and Myelomeningocele, sponsored by The University of Texas Health Science Center, Houston.

Active
Registry status
NA
Development phase
50
Enrollment target
1
Study location

NCT04243889: Active NA study of Spina Bifida and Myelomeningocele, sponsored by The University of Texas Health Science Center, Houston.

NCT04243889 is a NA study of Spina Bifida and Myelomeningocele that is active but no longer recruiting, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 50 participants, roughly in line with the 50-participant average among 16 other Spina Bifida trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04243889, a NA study of Spina Bifida and Myelomeningocele, is active but no longer recruiting, sponsored by The University of Texas Health Science Center, Houston.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

To fetoscopically use cryopreserved human umbilical cord allografts, named NEOX Cord 1K®, as a spinal cord cover of spina bifida defects. This procedure will be performed to create a watertight seal covering over the spinal cord in order to decrease the incidence rates of postnatal morbidities. For larger skin defects, NEOX Cord 1K® may be used as a skin cover.

Primary Outcome

A digital image of the fetal repair site will be captured during and immediately after the repair. The images will be sent to three independent blinded neurosurgeons for review of successful closure of the defect. More than best of three votes will be considered as the result.

Interventions

  • DEVICE NEOX Cord 1K

Study Locations (1)

Texas

  • The University of Texas Health Science Center at Houston - Houston

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2020-08-28
Est. Completion 2029-03-12
Phase NA

What the registry record for NCT04243889 still lists

NCT04243889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, roughly in line with the 50-participant average among 16 other Spina Bifida trials with a reported enrollment target.

The record links to 3 conditions, with Spina Bifida appearing as the primary indexed condition, and to 1 intervention - of which NEOX Cord 1K is the first listed.

NCT04243889 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT04243889 about?

NCT04243889 is a clinical study titled "Fetoscopic NEOX Cord 1K® Spina Bifida Repair". To fetoscopically use cryopreserved human umbilical cord allografts, named NEOX Cord 1K®, as a spinal cord cover of spina bifida defects. This procedure will be performed to create a watertight seal covering over the spinal cord in order to decrease the incidence rates of postnatal morbidities. For ...

What is the current status of trial NCT04243889?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2020-08-28. Estimated completion is 2029-03-12.

What conditions does trial NCT04243889 study?

This clinical trial studies the following conditions: Spina Bifida, Myelomeningocele, Myeloschisis.

What interventions are being tested in trial NCT04243889?

The interventions under investigation include: NEOX Cord 1K (DEVICE).

Who is sponsoring clinical trial NCT04243889?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04243889 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Spina Bifida

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04243889's enrollment target sits among peer trials

50 6th of 16 higher than 11 of 16 other Spina Bifida trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Spina Bifida trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04243889, the US trial registry maintained by the National Library of Medicine. NCT04243889 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.