A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
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ClinicalTrials.gov Identifier: NCT00196196 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Results First Posted
: December 5, 2008
Last Update Posted
: May 28, 2012
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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) |
Primary Purpose: | Treatment |
Official Title: | A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System. |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | October 2006 |
Actual Study Completion Date : | October 2006 |
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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)

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- A CODMAN Hakim Programmable Valve (CHPV) has been implanted for the management of the Subject's Hydrocephalus.
- The Subject has given written informed consent prior to enrolling in the study.
- The Subject requires adjustment of the CODMAN Hakim Programmable Valve (CHPV) for the management of Hydrocephalus·
- The Subject's implanted CHPV will be adjusted using the Implanted Valve Mode.
Exclusion Criteria:
- The Subject's valve is located in the deep lumbar position.
- The Subject has an open and/or recent wound site in the region of the implanted valve.
- The Subject has a history of Ultrasound gel allergies.
- The Subject is a prisoner.
- The subject has been previously enrolled in this protocol.

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 |
Publications:
Responsible Party: | Codman & Shurtleff |
ClinicalTrials.gov Identifier: | NCT00196196 History of Changes |
Other Study ID Numbers: |
VPV-US03-001 |
First Posted: | September 20, 2005 Key Record Dates |
Results First Posted: | December 5, 2008 |
Last Update Posted: | May 28, 2012 |
Last Verified: | February 2011 |
Keywords provided by Codman & Shurtleff:
Hydrocephalus Codman Hakim Programmable Valve Programmable Valve Shunt System |
Additional relevant MeSH terms:
Hydrocephalus Hydrocephalus, Normal Pressure Brain Diseases Central Nervous System Diseases Nervous System Diseases |