CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 274 enrolled
Drug / intervention
Codman VPV Systemdevice
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Codman Hakim Programmable Valve (CHPV) previously implanted for hydrocephalus management
  • ✓Requires adjustment of the implanted CHPV for hydrocephalus management
  • ✓Implanted valve will be adjusted using Implanted Valve Mode
Key exclusion· 5
  • ✕Valve located in deep lumbar position
  • ✕Open and/or recent wound at valve implant site
  • ✕History of ultrasound gel allergy
  • ✕Prisoner status

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00196196
NCT00196196Phase 3Completed
CompareCT.gov

A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.

Codman & Shurtleff·interventional·Posted Sep 20, 2005·Updated May 28, 2012

In Brief

A Phase 3 clinical trial evaluating Codman VPV System for Hydrocephalus and Normal Pressure Hydrocephalus. Completed, enrolled 274 participants across 8 sites.

Detailed Summary

The purpose of this study is to determine the agreement rate between the CODMAN Valve Position Verification (VPV) adjustment outcome (reprogramming) and X-ray verification in order to support an alternative to X-ray confirmation with respect to the valve adjustment process.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHydrocephalus, Normal Pressure Hydrocephalus
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartSep 1, 2004
Primary CompletionOct 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 20.8 years ago

Interventions

Codman VPV Systemdevice

Valve Positioning Verification (VPV) System