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NCT04177914 · ClinicalTrials.gov registry record · Phase 3

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

A Phase 3 study of Hydrocephalus, sponsored by University of Utah.

Recruiting
Registry status
Phase 3
Development phase
176
Enrollment target
20
Study locations

NCT04177914 is a Phase 3 study of Hydrocephalus that is actively recruiting participants, run by University of Utah. The registered enrollment target is 176 participants, above the 123-participant average among 17 other Hydrocephalus trials with a reported enrollment target (43% higher). The trial reports 20 study locations across 18 states.

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The verdict

NCT04177914, a Phase 3 study of Hydrocephalus, is actively recruiting participants, sponsored by University of Utah.

RECRUITING
Registry status
Phase 3
Development phase
176 participants
Enrollment target
20
Study locations

Study Summary

Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellectual outcome as shunt. Therefore, the investigators propose a randomized trial to compare intellectual outcome and brain structural integrity between these two treatments, to help families make the best treatment decision for their baby.

Conditions Studied

Hydrocephalus

Interventions

  • PROCEDURE Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)
  • DEVICE Ventriculoperitoneal Shunt

Study Locations (20)

Florida

  • Wolfson Children's Hospital - Jacksonville
  • Arnold Palmer Hospital for Children - Orlando

Pennsylvania

  • Children's Hospital of Pittsburgh of UPMC - Pittsburgh
  • The Pennsylvania State University - University Park

Alabama

  • Children's of Alabama - Birmingham

Arizona

  • Phoenix Children's Hospital - Phoenix

California

  • Children's Hospital of Los Angeles - Los Angeles

Colorado

  • Children's Hospital Colorado - Aurora

Connecticut

  • Yale University - New Haven

Indiana

  • Trustees of Indiana University - Indianapolis

Trial Details

FieldValue
Enrollment Target 176 participants
Start Date 2020-07-21
Est. Completion 2027-08-31
Phase Phase 3

Sponsor

University of Utah

818 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04177914

The ClinicalTrials.gov registry entry for NCT04177914 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 123-participant average among 17 other Hydrocephalus trials with a reported enrollment target (43% higher). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hydrocephalus appearing as the primary indexed condition, and to 2 interventions - of which Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC) is the first listed.

NCT04177914 reports 20 study locations spanning 18 distinct geographic areas - top geographies include Florida, Pennsylvania, Alabama.

Frequently Asked Questions

What is clinical trial NCT04177914 about?

NCT04177914 is a clinical study titled "HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants". Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complicati...

What is the current status of trial NCT04177914?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 176 participants. The study started on 2020-07-21. Estimated completion is 2027-08-31.

What conditions does trial NCT04177914 study?

This clinical trial studies the following conditions: Hydrocephalus.

What interventions are being tested in trial NCT04177914?

The interventions under investigation include: Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC) (PROCEDURE), Ventriculoperitoneal Shunt (DEVICE).

Who is sponsoring clinical trial NCT04177914?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04177914 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. 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.