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NCT03674372 · ClinicalTrials.gov registry record · NA

Fetoscopic Endoluminal Tracheal Occlusion

A NA study of Congenital Diaphragmatic Hernia, sponsored by University of Colorado, Denver.

Recruiting
Registry status
NA
Development phase
10
Enrollment target
1
Study location

NCT03674372 is a NA study of Congenital Diaphragmatic Hernia that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 10 participants, below the 196-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03674372, a NA study of Congenital Diaphragmatic Hernia, is actively recruiting participants, sponsored by University of Colorado, Denver.

RECRUITING
Registry status
NA
Development phase
10 participants
Enrollment target
1
Study location

Study Summary

The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.

Conditions Studied

Congenital Diaphragmatic Hernia

Interventions

  • DEVICE Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Study Locations (1)

Colorado

  • Children's Hospital Colorado - Aurora

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2018-11-16
Est. Completion 2030-03
Phase NA

Sponsor

University of Colorado, Denver

1,283 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03674372

The ClinicalTrials.gov registry entry for NCT03674372 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 196-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (95% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Congenital Diaphragmatic Hernia appearing as the primary indexed condition, and to 1 intervention - of which Fetoscopic Endoluminal Tracheal Occlusion (FETO) is the first listed.

NCT03674372 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT03674372 about?

NCT03674372 is a clinical study titled "Fetoscopic Endoluminal Tracheal Occlusion". The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to mov...

What is the current status of trial NCT03674372?

This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2018-11-16. Estimated completion is 2030-03.

What conditions does trial NCT03674372 study?

This clinical trial studies the following conditions: Congenital Diaphragmatic Hernia.

What interventions are being tested in trial NCT03674372?

The interventions under investigation include: Fetoscopic Endoluminal Tracheal Occlusion (FETO) (DEVICE).

Who is sponsoring clinical trial NCT03674372?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03674372 being conducted?

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

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