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

Completed · Phase 3

Conditions studied: Hydrocephalus, Normal Pressure Hydrocephalus

In brief

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.

Key facts

Study ID

NCT00196196

Run by

Codman & Shurtleff

People needed

274

Starts

2004-09-01

Expected to finish

2006-10-01

Last updated by the study team

2012-05-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Orlando, Florida, United States
• Study site — Boston, Massachusetts, United States
• Study site — Newark, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Richardson, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.