Clinical Trials Logo
  1. Home
  2. Normal Pressure Hydrocephalus
  3. NCT00196196

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

Hydrocephalus Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

Patients with Hydrocephalus, managed with an implanted Codman HakimTM Programmable Valve (CHPV), occasionally visit their physician to have their valve adjusted to a different setting to manage their condition. After the adjustment, an x-ray of the skull is taken to confirm the valve setting.

The Codman VPV System is designed to facilitate and confirm the adjustment of a CHPV. After signing the informed consent, Subjects will be enrolled in the study and have their CHPV adjusted using the Codman VPV System. After the adjustment, an x-ray of the skull will be taken to verify the valve setting. No further follow up visit is needed after the adjustment.

This study is expected to enroll about 300 Subjects from up to 20 sites in the United States. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00196196
Study type Interventional
Source Codman & Shurtleff
Contact
Status Completed
Phase Phase 3
Start date September 2004
Completion date October 2006
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06040697 - Formative Usability Assessment of Wireless Thermal Anisotropy Devices
Terminated NCT02408757 - Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages
Terminated NCT01863381 - Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement N/A
Completed NCT00652470 - A Study Comparing Two Treatments for Infants With Hydrocephalus Phase 2
Terminated NCT05501002 - Pilot Study to Evaluate the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus N/A
Active, not recruiting NCT05068128 - Combined Flow and Pressure Study of Craniospinal Dynamic
Completed NCT04496414 - Bactiseal Catheter Safety Registry in China
Terminated NCT02900222 - Study of Choroid Plexus Cauterization in Patients With Hydrocephalus N/A
Recruiting NCT04099823 - MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics N/A
Unknown status NCT02775136 - An Evaluation of a Non-invasive Brain Monitor N/A
Completed NCT00692744 - Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH) N/A
Recruiting NCT04758611 - The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt) N/A
Completed NCT03595033 - Hydrocephalus iPad-App Based Intervention Study N/A
Completed NCT04207229 - CERTAS Programmable Valve Registry
Terminated NCT01973764 - Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System N/A
Completed NCT01976559 - Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol N/A
Completed NCT02381977 - Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment N/A
Recruiting NCT06086561 - Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device N/A
Recruiting NCT05910944 - European Study of Prodromal iNPH
Recruiting NCT03650101 - Improving Infant Hydrocephalus Outcomes in Uganda