CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
MIETHKE proGAV® / MIETHKE proSA®device
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.

Search/NCT01798641
NCT01798641N/ACompleted
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Efficacy of Shunt Surgery in Normal Pressure Hydrocephalus: a Randomized Cross-over Study

Johns Hopkins University·interventional·Posted Feb 26, 2013·Updated Nov 2, 2018

In Brief

A clinical study evaluating MIETHKE proGAV® / MIETHKE proSA® for Normal Pressure Hydrocephalus. Completed, enrolled 48 participants across 5 sites.

Detailed Summary

The goal of our study is to verify the effectiveness of the shunt and to identify the most sensitive criteria to select patients for surgery. The study is designed to assess improvement in walking and balance (gait), urinary function and memory after shunting. In addition, the study aims to identify the most accurate and sensitive tools to measure improvement for our patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNormal Pressure Hydrocephalus
CountriesUnited States
CollaboratorsAesculap, Inc., Ohio State University, Rhode Island Hospital, Virginia Commonwealth University, Henry Ford Health System

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 26, 2013
Enrollment StartJan 1, 2013
Primary CompletionSep 14, 2017
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.3 years ago

Interventions

MIETHKE proGAV® / MIETHKE proSA®device

The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed. The closed shunt will be adjusted to open.