A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
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.
Normal Pressure Hydrocephalus
Device: Codman VPV System
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.|
- Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Up to 5 attempts to achieve "Adjustment Complete" using the Codman Valve Position Verification (VPV) system for each Subject. Agreement in 2 of 3 valve X-ray readings by independent radiologists for each Subject was considered "consensus X-ray". All participants included achieved "Adjustment Complete" and a "consensus X-ray reading".
- Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Percentage of agreement between consensus X-ray readings and the intended setting programmed by the Codman Valve Position Verification (VPV) system. This was assessed at various steps (intervals of mmH20) as increments allow on the Codman Hakim Programmable Valve. (1 step = 10 mmH20, 2 steps = 20 mmH20, +2 steps = >20 mmH20)
|Study Start Date:||September 2004|
|Study Completion Date:||October 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Device: Codman VPV System
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.
|United States, Arizona|
|Phoenix, Arizona, United States|
|United States, Florida|
|Orlando, Florida, United States|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|United States, New Jersey|
|Newark, New Jersey, United States|
|United States, New York|
|New York, New York, United States|
|United States, Ohio|
|Cleveland, Ohio, United States|
|United States, Oregon|
|Portland, Oregon, United States|
|United States, Texas|
|Richardson, Texas, United States|
|Study Director:||J. Thomas Megerian, MD||Codman & Shurtleff|