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NCT03856034 · ClinicalTrials.gov registry record · NA

Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele

A NA study of Spina Bifida and Myelomeningocele, sponsored by USFetus.

Recruiting
Registry status
NA
Development phase
12
Enrollment target
2
Study locations

NCT03856034 is a NA study of Spina Bifida and Myelomeningocele that is actively recruiting participants, run by USFetus. The registered enrollment target is 12 participants, below the 52-participant average among 16 other Spina Bifida trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03856034, a NA study of Spina Bifida and Myelomeningocele, is actively recruiting participants, sponsored by USFetus.

RECRUITING
Registry status
NA
Development phase
12 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.

Interventions

  • DEVICE Fetoscopy

Study Locations (2)

California

  • University of Southern California / Huntington Memorial Hospital - Los Angeles

Florida

  • Wellington Regional Medical Center - Wellington

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2018-11-02
Est. Completion 2027-12-31
Phase NA

Sponsor

USFetus

1 total trials

What the Registry Record Tells You About NCT03856034

The ClinicalTrials.gov registry entry for NCT03856034 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 52-participant average among 16 other Spina Bifida trials with a reported enrollment target (77% lower). The listed sponsor is USFetus, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Spina Bifida appearing as the primary indexed condition, and to 1 intervention - of which Fetoscopy is the first listed.

NCT03856034 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Florida.

Frequently Asked Questions

What is clinical trial NCT03856034 about?

NCT03856034 is a clinical study titled "Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele". The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteri...

What is the current status of trial NCT03856034?

This trial is currently recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2018-11-02. Estimated completion is 2027-12-31.

What conditions does trial NCT03856034 study?

This clinical trial studies the following conditions: Spina Bifida, Myelomeningocele, Neural Tube Defects, Chiari Malformation.

What interventions are being tested in trial NCT03856034?

The interventions under investigation include: Fetoscopy (DEVICE).

Who is sponsoring clinical trial NCT03856034?

This trial is sponsored by USFetus, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03856034 being conducted?

This trial has 2 study locations across California, Florida. 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.