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Endoscopic Treatment vs. Shunt Surgery for Hydrocephalus (ESTHI Trial)

Phase 3
Recruiting
Led By Abhaya Kulkarni, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)
Corrected age <104 weeks and 0 days
Must not have
Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, a maximum of 7 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare two different treatments for hydrocephalus in babies. One is a shunt between the brain and abdomen, and the other is an endoscopic procedure. They will compare outcomes and brain structural integrity to help families make the best decision for their baby.

Who is the study for?
This trial is for babies under 2 years old with symptomatic hydrocephalus, a condition where fluid builds up in the brain. They should have no prior shunt or endoscopic procedures and meet specific criteria on MRI scans and symptoms like head size, eye movement issues, or irritability without other causes.
What is being tested?
The study compares two treatments for infant hydrocephalus: a traditional shunt insertion versus an endoscopic procedure that might avoid the need for a shunt. The goal is to see which treatment leads to better intellectual development and brain structure.
What are the potential side effects?
Potential side effects of both treatments may include infection risk at the surgery site, possible damage during surgery leading to neurological issues, and complications related to device malfunction in case of shunt placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never had a shunt insertion or ETV procedure.
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My child is less than 2 years old.
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My child is at least 37 weeks post menstrual age.
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My child has severe brain swelling shown on MRI and symptoms like a very large head, eye movement issues, or unexplained vomiting.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My child was born prematurely and has hydrocephalus from bleeding in the brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, a maximum of 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, a maximum of 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bayley Scale of Infant Development-IV (Bayley-IV) Cognitive Scale score
Secondary study objectives
Bayley Scale of Infant Development-IV (Bayley-IV) Language Scaled Score
Bayley Scale of Infant Development-IV (Bayley-IV) Motor Scaled Score
Other study objectives
All major peri-operative and post-operative complications
Brain and ventricle volume on MRI performed at 12 months after surgery
Cerebral spinal fluid NCAM-1 levels measured at the time of ETV+CPC or shunt
+16 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Ventriculoperitoneal ShuntActive Control1 Intervention
Subjects randomized to this arm will undergo a Ventriculoperitoneal Shunt procedure for treatment of Hydrocephalus
Group II: ETV+CPCActive Control1 Intervention
Subjects randomized to this arm will undergo an ETV+CPC procedure for treatment of Hydrocephalus

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityOTHER
716 Previous Clinical Trials
22,888,322 Total Patients Enrolled
1 Trials studying Hydrocephalus
48 Patients Enrolled for Hydrocephalus
University of UtahLead Sponsor
1,141 Previous Clinical Trials
1,697,623 Total Patients Enrolled
7 Trials studying Hydrocephalus
2,187 Patients Enrolled for Hydrocephalus
University of PittsburghOTHER
1,789 Previous Clinical Trials
16,359,447 Total Patients Enrolled
2 Trials studying Hydrocephalus
1,370 Patients Enrolled for Hydrocephalus

Media Library

Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC) Clinical Trial Eligibility Overview. Trial Name: NCT04177914 — Phase 3
Hydrocephalus Research Study Groups: Ventriculoperitoneal Shunt, ETV+CPC
Hydrocephalus Clinical Trial 2023: Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC) Highlights & Side Effects. Trial Name: NCT04177914 — Phase 3
Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04177914 — Phase 3
~64 spots leftby May 2027
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