Status:
COMPLETED
A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
Lead Sponsor:
Codman & Shurtleff
Conditions:
Hydrocephalus
Normal Pressure Hydrocephalus
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 alter...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT00196196
Start Date
September 1 2004
End Date
October 1 2006
Last Update
May 28 2012
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Phoenix, Arizona, United States
2
Orlando, Florida, United States
3
Boston, Massachusetts, United States, 02115
4
Newark, New Jersey, United States