A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00196196|
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : December 5, 2008
Last Update Posted : May 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hydrocephalus Normal Pressure Hydrocephalus||Device: Codman VPV System||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||274 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.|
|Study Start Date :||September 2004|
|Primary Completion Date :||October 2006|
|Study Completion Date :||October 2006|
Device: Codman VPV System
- Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading [ Time Frame: Day 1 ]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 ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196196
|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|