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

Q: Are there any specific inclusion criteria for this research study?

<p>This study is looking for 176 participants who have hydrocephalus and are between 0 days and 104 weeks old. To be eligible, patients should meet the following criteria: corrected age &#x3C;104 weeks and 0 days, child is ≥ 37 weeks post menstrual age, head circumference >98th percentile for corrected age with either bulging fontanelle or splayed sutures, upgaze paresis/palsy (sundowning), CSF leak, papilledema, tense pseudomeningocele or tense fluid along a track, vomiting or irritability with no other attributable cause, bradycardias or ap</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, a maximum of 7 years

Awards & highlights

ESTHI 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.Check my eligibility

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.See study design

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.

ESTHI Trial 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.

ESTHI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, a maximum of 7 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bayley Scale of Infant Development-IV (Bayley-IV) Cognitive Scale score

Secondary outcome measures

Bayley Scale of Infant Development-IV (Bayley-IV) Language Scaled Score

Bayley Scale of Infant Development-IV (Bayley-IV) Motor Scaled Score

Other outcome measures

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

+15 more

ESTHI 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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,099 Previous Clinical Trials

1,778,546 Total Patients Enrolled

7 Trials studying Hydrocephalus

2,187 Patients Enrolled for Hydrocephalus

University of PittsburghOTHER

1,721 Previous Clinical Trials

16,343,040 Total Patients Enrolled

2 Trials studying Hydrocephalus

1,370 Patients Enrolled for Hydrocephalus

Seattle Children's HospitalOTHER

302 Previous Clinical Trials

5,216,831 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any specific inclusion criteria for this research study?

"This study is looking for 176 participants who have hydrocephalus and are between 0 days and 104 weeks old. To be eligible, patients should meet the following criteria: corrected age <104 weeks and 0 days, child is ≥ 37 weeks post menstrual age, head circumference >98th percentile for corrected age with either bulging fontanelle or splayed sutures, upgaze paresis/palsy (sundowning), CSF leak, papilledema, tense pseudomeningocele or tense fluid along a track, vomiting or irritability with no other attributable cause, bradycardias or ap"

Answered by AI

What is the FDA's official stance on Ventriculoperitoneal Shunt?

"This medical device has been shown to be effective in multiple clinical trials, and therefore it is considered safe."

Answered by AI

How many people will be taking part in this experiment at most?

"In order for this clinical trial to commence, 176 individuals that fit the Bill of Health, so to speak, need to enroll. From there, patients can begin participating in the study from locations such as Johns Hopkins Children's Center in Baltimore, Maryland and Monroe Carell Jr. Children's Hospital at Vanderbilt in Nashville, Tennessee."

Answered by AI

Are we still able to register for this clinical trial?

"The trial, which is currently seeking patients, was originally posted on clinicaltrials.gov on 7/21/2020. The listing was last updated on 7/20/2022"

Answered by AI

How many hospitals are testing this new medication?

"In total, there are 16 hospitals participating in this trial - some notable ones include Johns Hopkins Children's Center in Baltimore, Monroe Carell Jr. Children's Hospital at Vanderbilt in Nashville, and Children's of Alabama in Birmingham."

Answered by AI