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NCT01801267 · ClinicalTrials.gov registry record · NA
Third Ventriculostomy Versus Shunt for Children With Hydrocephalus
A NA study of Communicating Hydrocephalus, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT01801267 is a NA study of Communicating Hydrocephalus that has completed, run by Duke University. The registered enrollment target is 8 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01801267, a NA study of Communicating Hydrocephalus, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study 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 long been assumed that endoscopic third ventriculostomy (ETV) would not work in this population and is better suited to patients with obstructive hydrocephalus (such as from a tumor blocking cerebral-spinal fluid (CSF) pathways). However, as scientists learn more about CSF and the way our brains absorb this fluid, they have learned that this may not be so straight-forward. Recent small studies have shown that ETVs can work in a good percentage of children with communicating hydrocephalus, too. But no randomized controlled trials have been done to compare these two treatments directly to determine which will provide children with a better prognosis, fewer surgeries over their lifetime, less time in the hospital and the greatest chance at as normal a life as possible. The investigators will conduct a trial to compare these two surgical treatments where patients will be randomized to receive either a shunt or an ETV. Because ETV has been shown to have a high failure rate in newborns, the investigators will not include these patients and instead will study patients who come to Duke University with communicating hydrocephalus between the ages of 1 year and 18 years. The study will include patients with ventricular shunts who are in need of revision and patients who were just diagnosed and need their first shunt. All patients who agree to participate will be randomized to receive either an ETV or a shunt. The study team will follow them for one year from the time of the surgery and will determine what percentage of patients require further CSF-related surgeries, how long they go after their surgery before they need another surgery, how much time they spend in the hospital and what percentage of patients suffer CSF-infections or other problems related to the surgery or thei
Conditions Studied
Interventions
- PROCEDURE Endoscopic third ventriculostomy (ETV)
- PROCEDURE Ventricular shunt
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01801267
The ClinicalTrials.gov registry entry for NCT01801267 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Communicating Hydrocephalus appearing as the primary indexed condition, and to 2 interventions - of which Endoscopic third ventriculostomy (ETV) is the first listed.
NCT01801267 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01801267 about?
NCT01801267 is a clinical study titled "Third Ventriculostomy Versus Shunt for Children With Hydrocephalus". 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 long been assumed that endoscopic third ventriculostomy (ETV) would not work in this population and...
What is the current status of trial NCT01801267?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2013-08. Estimated completion is 2015-12.
What conditions does trial NCT01801267 study?
This clinical trial studies the following conditions: Communicating Hydrocephalus.
What interventions are being tested in trial NCT01801267?
The interventions under investigation include: Endoscopic third ventriculostomy (ETV) (PROCEDURE), Ventricular shunt (PROCEDURE).
Who is sponsoring clinical trial NCT01801267?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01801267 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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