NCT00196196

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Codman & Shurtleff · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hydrocephalus
• Normal Pressure Hydrocephalus

Interventions

Type	Name	Description
DEVICE	Codman VPV System	Valve Positioning Verification (VPV) System

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2005-09-20
• Last updated: 2012-05-28
• Results posted: 2008-12-05

Locations

8 sites across 1 country: United States