Clinical trial NCT00196196: A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
Official title: A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hydrocephalus
Normal Pressure Hydrocephalus
Keywords: Hydrocephalus
Codman Hakim Programmable Valve
Programmable Valve
Shunt System
Lead sponsor: Codman & Shurtleff
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 274
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 alternative to X-ray confirmation with respect to the valve adjustment process.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds
timeFrame: Day 1
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Orlando
country: United States
state: Florida
city: Boston
country: United States
state: Massachusetts
city: Newark
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Richardson
country: United States
state: Texas
Study officials:
affiliation: Codman & Shurtleff
name: J. Thomas Megerian, MD
role: STUDY_DIRECTOR
References:
citation: Bret P, Guyotat J, Ricci AC, Mottolese C, Jouanneau E. [Clinical experience with the Sp[hy adjustable valve in the treatment of adult hydrocephalus. A series of 147 cases]. Neurochirurgie. 1999 May;45(2):98-108; discussion 108-9. French.
citation: Petrie A, Sabin C. Medical Statistics at a Glance. Blackwell Science Ltd: 90-91
citation: American Society of Radiologic Technologists, Statement on IOM Report, "To Err Is Human: Building a Safer Health System", www.asrt.org/other_categories/government_relations/iom_report.htm
citation: Pollack IF, Albright AL, Adelson PD. A randomized, controlled study of a programmable shunt valve versus a conventional valve for patients with hydrocephalus. Hakim-Medos Investigator Group. Neurosurgery. 1999 Dec;45(6):1399-408; discussion 1408-11. doi: 10.1097/00006123-199912000-00026.
citation: Rohde V, Mayfrank L, Ramakers VT, Gilsbach JM. Four-year experience with the routine use of the programmable Hakim valve in the management of children with hydrocephalus. Acta Neurochir (Wien). 1998;140(11):1127-34. doi: 10.1007/s007010050226.
citation: Zemack G, Romner B. Seven years of clinical experience with the programmable Codman Hakim valve: a retrospective study of 583 patients. J Neurosurg. 2000 Jun;92(6):941-8. doi: 10.3171/jns.2000.92.6.0941.