HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Recruiting
Phase 3
Interventional Study
Hydrocephalus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Day – 104 Weeks
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 176 (estimated)
- Sponsor
- University of Utah · Other
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About This Trial
Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellec…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Corrected age \<104 weeks and 0 days,
AND
2. Child is ≥ 37 weeks post menstrual age,
AND
3. Child must have symptomatic hydrocephalus, defined as:
Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) \>0.45, which approximates "moderate ventriculomegaly"), a…
Contacts