Status:
COMPLETED
Third Ventriculostomy Versus Shunt for Children With Hydrocephalus
Lead Sponsor:
Duke University
Collaborating Sponsors:
Pediatric Hydrocephalus Foundation
Children's Miracle Network Hospitals
Conditions:
Communicating Hydrocephalus
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief Summary
Ventriculoperitoneal shunts are the standard of care for patients with communicating hydrocephalus, but they have a high failure rate - up to 40% fail within 1 year and 50% fail within 2 years. It has...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01801267
Start Date
August 1 2013
End Date
December 1 2015
Last Update
March 8 2016
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710