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A Randomized Controlled Trial of Endoscopic Third Ventriculostomy Versus Ventricular Shunt for Children With Communicating Hydrocephalus


Phase 2
1 Year
18 Years
Not Enrolling
Both
Communicating Hydrocephalus

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Trial Information

A Randomized Controlled Trial of Endoscopic Third Ventriculostomy Versus Ventricular Shunt for Children With Communicating Hydrocephalus


Inclusion Criteria:



- Children age 1-18 years

- Patients with communicating hydrocephalus who present in need of CSF diversion
surgery, as diagnosed by radiographic imaging (CT or MRI of brain) as well as
clinical signs or symptoms of increased intracranial pressure

- Informed consent according to institutional guidelines must be obtained from each
patient's parent or legal guardian, or by the patient him/herself if he/she is 18
years of age

Exclusion Criteria:

- An active Central Nervous System malignancy (cancer)

- The presence of two or more current ventricular catheters indicating that the
ventricles do not communicate with each other

- The inability of the parent/guardian or patient to provide informed consent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time until need for further CSF-related surgeries

Outcome Description:

The measurement will be the time between the initial randomized study surgery and any additional CSF-related surgery that the patient needs for a maximum of one year.

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Carrie R Muh, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00043098

NCT ID:

NCT01801267

Start Date:

Completion Date:

December 2015

Related Keywords:

  • Communicating Hydrocephalus
  • Hydrocephalus
  • Pediatric
  • Ventricular shunt
  • Ventriculoperitoneal shunt
  • Third ventriculostomy
  • Randomized controlled trial
  • Hydrocephalus

Name

Location
Duke University Medical Center Durham, North Carolina  27710