At a glance
ClinicalIndex Comparison RecordN/ACompleted· 18 enrolled
Drug / intervention
programmable CSF shunt valvedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial: Proof of Concept
In Brief
A clinical study evaluating programmable CSF shunt valve for Idiopathic Normal Pressure Hydrocephalus (INPH). Completed, enrolled 18 participants across 7 sites in 3 countries.
Detailed Summary
The Placebo-Controlled Effectiveness in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt effectiveness in iNPH patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Sweden, United States
CollaboratorsUniversity of Utah, Integra LifeSciences Corporation
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartMay 2018
Primary CompletionMar 2021
Study CompletionMay 2021
TodayJul 2026
First PostedNov 22, 2017
Enrollment StartMay 21, 2018
Primary CompletionMar 19, 2021
Study CompletionMay 18, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.6 years ago
Interventions
programmable CSF shunt valvedevice
Brain shunt surgery using a programmable CSF shunt valve