Recruiting
Phase 3

Endoscopic & Shunt

Sponsor:

University of Utah

Code:

NCT04177914

Conditions

Hydrocephalus

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)

Ventriculoperitoneal Shunt

Study Details

Brief 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

Hydrocephalus

Study ID

NCT04177914

Start date

Jul 21, 2020

Status verified date

Jun, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Corrected age <104 weeks and 0 days,

AND
2. Child is ≥ 37 weeks post menstrual age,

AND
3. Child must have symptomatic hydrocephalus, defined as:

Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) >0.45, which approximates "moderate ventriculomegaly"), and at least one of the following:
  • 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 apneas, with no other attributable cause
  • Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves

AND
4. No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)

Exclusion Criteria:

1. Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR
2. Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt defined as:

  • Moderate to severe prepontine adhesions on steady state free precession (SSFP) or T2 weighted fast (turbo) spin echo (FSE/TSE) MRI, which includes the following sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE), CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX
  • Closure of one or both foramina of Monro
  • Thick floor of third ventricle (≥ 3mm)
  • Narrow third ventricle (<5mm)
  • Presence of scalp, bone, or ventricular lesions that make placement of an anterior shunt impracticable; OR
3. Underlying condition with a high chance of mortality within 12 months; OR
4. Hydrocephalus with loculated CSF compartments; OR
5. Peritoneal cavity not suitable for distal shunt placement; OR
6. Active CSF infection; OR
7. Hydranencephaly; OR
8. Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: ETV+CPC

Subjects randomized to this arm will undergo an ETV+CPC procedure for treatment of Hydrocephalus

active comparator: Ventriculoperitoneal Shunt

Subjects randomized to this arm will undergo a Ventriculoperitoneal Shunt procedure for treatment of Hydrocephalus

Interventions

Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)

Since the early 1990s, ETV has become the main alternative to shunting for hydrocephalus. This procedure involves placing an endoscopic camera into the ventricles of the brain and creating a hole in the floor of the third ventricle to act as an internal bypass for obstructed CSF. The cauterization of choroid plexus (CPC) involves the use of a device to burn or cauterize tissue from the choroid plexus. The choroid plexus of the brain exists in the lateral ventricles, the third ventricle, and the fourth ventricle. Its main role is the production of CSF. The success of ETV alone is poor in infants, but when combined with CPC, improved results have been observed and ETV+CPC has become a safe viable option for these children.

Ventriculoperitoneal Shunt

The most common treatment for hydrocephalus has been the insertion of a ventriculoperitoneal shunt, which has been in popular use for over 50 years. This consists of silastic tubing attached to a valve mechanism that runs subcutaneously from the head to the abdomen. It is one of the most common procedures performed by pediatric neurosurgeons.

Primary outcome measure

  • Bayley Scale of Infant Development-IV (Bayley-IV) Cognitive Scale score [ Time Frame: 12 months post randomized surgical intervention ]

Central Contacts and Locations

Central contacts

Nichol Nunn

801-458-6593nichol.nunn@hsc.utah.edu

Jason Clawson

jason.clawson@hsc.utah.edu

Locations

Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Anastasia Smith, MPH

205-638-5018Anastasia.Smith@childrensal.org

Principal Investigator:

Curtis Rozzelle, MD

Children's Hospital of Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Helen Berroya

hberroya@chla.usc.edu

Principal Investigator:

Mark Krieger, MD

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Susan Staulcup, 80045

303-724-5935SUSAN.STAULCUP@UCDENVER.EDU

Principal Investigator:

Todd Hankinson, MD

Wolfson Children's Hospital

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Asmaa Hatem

904-633-0993Asmaa.Hatem@jax.ufl.edu

Principal Investigator:

Philipp R. Aldana, MD

Arnold Palmer Hospital for Children

Recruiting

Orlando, Florida, United States, 32806

Contacts

Richard Guerrero

richard.guerrero@orlandohealth.com

Principal Investigator:

Samer Elbabaa, MD

Johns Hopkins Children's Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Sydney White

swhit128@jh.edu

Principal Investigator:

Eric Jackson, MD

St. Louis Children's Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Diego Morales, MS

314-454-4688moralesd@wudosis.wustl.edu

Mary Goldschmidt

goldschmidt@wustl.edu

Principal Investigator:

Jennifer Strahle, MD, PhD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Jared Haught

Jared.Haught@nationwidechildrens.org

Principal Investigator:

Jonathan Pindrik, MD

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Kimberly Diamond, BS, BA

412-692-9965diamondkl@upmc.edu

Principal Investigator:

Ian Pollack, MD

Monroe Carell Jr. Children's Hospital at Vanderbilt

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Julia Loes

julia.loes@vumc.org

Stephen Gannon

615-936-6809stephen.r.gannon@vumc.org

Principal Investigator:

John C. Wellons, III, MD, MSPH

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Edgardo Santisbon

832-826-5208exsantis@texaschildrens.org

Principal Investigator:

William E. Whitehead, MD, MPH

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84118

Contacts

Alli Ludwick

801-662-5352allison.ludwick@hsc.utah.edu

Principal Investigator:

John Kestle, MD

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Jessica Becerra

Jessica.Becerra@seattlechildrens.org

Principal Investigator:

Hannah Goldstein, MD

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Ruksana Rashid, MBBS MPH MSc

403-955-5738rsrashid@ucalgary.ca

Principal Investigator:

Jay Riva-Cambrin, MD

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

Contacts

Annika Weirs

annika.weir@cw.bc.ca

Principal Investigator:

Mandeep Tamber, MD, PhD

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Homa Ashrafpour

416-813-7654homa.ashrafpour@sickkids.ca

Principal Investigator:

Abhaya Kulkarni, MD, PhD

More Information

Sponsor

University of Utah

Last update posted

Jun 11, 2025

Last verified

Jun, 2025

Keywords

  • Hydrocephalus
  • Infants
  • Ventriculoperitoneal Shunt
  • ETV+CPC
  • endoscopic third ventriculostomy
  • choroid plexus cauterization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-06-11.