Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-24 @ 12:04 PM
NCT ID:
NCT02425761
Eligibility Criteria:
Inclusion Criteria:
1. Less than 18 years of age at the time of shunt insertion; AND
2. Clinical evidence of hydrocephalus that requires a simple ventriculoperitoneal shunt as determined by a pediatric neurosurgeon; AND
3. No prior history of shunt insertion (a history of an external ventricular drain, ventricular reservoir, subgaleal shunt, and or endoscopic third ventriculostomy with or without choroid plexus coagulation is permissible); AND
4. Ventriculomegaly on imaging.
Exclusion Criteria:
1. Need of a shunt that is not a simple ventriculoperitoneal shunt. For example: Patients who require more than one intracranial catheter are excluded. Patients who require a ventricular shunt that terminates in the atrium of the heart, the pleural cavity, the gallbladder, or any other terminal location that is not the peritoneal cavity are excluded. Patients who require a subdural to peritoneal or a cyst to peritoneal shunt are excluded.
2. Active CSF or abdominal infection;
3. CSF leak without hydrocephalus;
4. Pseudotumor cerebri;
5. Hydranencephaly;
6. Loculations within the ventricular system (e.g. large intraventricular cysts or ventricular adhesions which create compartments that distort the ventricular anatomy; isolated trapped lateral ventricle). A small cyst within the ventricle does not meet these criteria;
7. Other difficulties that would preclude follow up at one year (e.g. terminal illness with life expectancy less than 18 months; family plans to move out of region or country);
8. A bilateral scalp, bone, or ventricular lesion that makes placement of either an anterior or a posterior shunt impracticable (e.g. cutis aplasia);
9. Bilateral slit like frontal horns or trigones defined as the widest distance between the medial and lateral walls less than 3 millimeters.
10. Patient is scheduled to have an intra-ventricular procedure (e.g. ETV, endoscopic biopsy, arachnoid cyst fenestration, fenestration of septum pellucidum) in addition to possible or definite VP shunt.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
17 Years
Study:
NCT02425761
Study Brief:
Protocol Section:
NCT02425761