HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

PHASE3RecruitingINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

July 21, 2020

Primary Completion Date

May 30, 2027

Study Completion Date

August 31, 2027

Conditions
Hydrocephalus
Interventions
PROCEDURE

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.

DEVICE

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.

Trial Locations (21)

15224

RECRUITING

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

16802

ACTIVE_NOT_RECRUITING

The Pennsylvania State University, University Park

21287

RECRUITING

Johns Hopkins Children's Center, Baltimore

23284

ACTIVE_NOT_RECRUITING

Virginia Commonwealth University, Richmond

32207

RECRUITING

Wolfson Children's Hospital, Jacksonville

32806

RECRUITING

Arnold Palmer Hospital for Children, Orlando

35233

RECRUITING

Children's of Alabama, Birmingham

37232

RECRUITING

Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville

43205

RECRUITING

Nationwide Children's Hospital, Columbus

46202

NOT_YET_RECRUITING

Trustees of Indiana University, Indianapolis

63110

RECRUITING

St. Louis Children's Hospital, St Louis

77030

RECRUITING

Texas Children's Hospital, Houston

80045

RECRUITING

Children's Hospital Colorado, Aurora

84118

RECRUITING

Primary Children's Hospital, Salt Lake City

85016

NOT_YET_RECRUITING

Phoenix Children's Hospital, Phoenix

90027

RECRUITING

Children's Hospital of Los Angeles, Los Angeles

98105

RECRUITING

Seattle Children's Hospital, Seattle

06520

ACTIVE_NOT_RECRUITING

Yale University, New Haven

T3B 6A8

RECRUITING

Alberta Children's Hospital, Calgary

V6H 3V4

RECRUITING

British Columbia Children's Hospital, Vancouver

M5G 1X8

RECRUITING

The Hospital for Sick Children, Toronto

All Listed Sponsors
collaborator

University of Alabama at Birmingham

OTHER

collaborator

University of British Columbia

OTHER

collaborator

University of Pittsburgh

OTHER

collaborator

The Hospital for Sick Children

OTHER

collaborator

Seattle Children's Hospital

OTHER

collaborator

Vanderbilt University Medical Center

OTHER

collaborator

Washington University School of Medicine

OTHER

collaborator

Nationwide Children's Hospital

OTHER

collaborator

Johns Hopkins University

OTHER

collaborator

University of Calgary

OTHER

collaborator

University of Colorado, Denver

OTHER

collaborator

Children's Hospital Los Angeles

OTHER

collaborator

National Institutes of Health (NIH)

NIH

collaborator

Hydrocephalus Association

OTHER

collaborator

Penn State University

OTHER

collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

collaborator

Baylor College of Medicine

OTHER

collaborator

University of Florida

OTHER

collaborator

Orlando Health, Inc.

OTHER

collaborator

Virginia Commonwealth University

OTHER

collaborator

Trustees of Indiana University

UNKNOWN

lead

University of Utah

OTHER

NCT04177914 - HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants | Biotech Hunter | Biotech Hunter