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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: Completed NA study of Communicating Hydrocephalus, sponsored by Duke University.
NCT01801267 is a NA study of Communicating Hydrocephalus that has completed, run by Duke University. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
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.
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 |
What the finished NCT01801267 record still lists
NCT01801267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01801267's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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