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RECRUITING Phase 3

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

NCT04177914 · View on ClinicalTrials.gov ↗

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

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

686 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 686 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04177914 reports 20 study locations spanning 18 distinct geographic areas — top geographies include Florida, Pennsylvania, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04177914?

This trial is sponsored by University of Utah, which has 686 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial