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

Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196196
• Other study ID #: VPV-US03-001
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 22, 2012
• Start date: September 2004
• Est. completion date: October 2006

Study information

• Verified date: February 2011
• Source: Codman & Shurtleff
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Normal Pressure Hydrocephalus

Intervention

Device:
• Codman VPV System
Valve Positioning Verification (VPV) System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Codman & Shurtleff

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

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. — View Citation

Petrie A, Sabin C. Medical Statistics at a Glance. Blackwell Science Ltd: 90-91

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading	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".	Day 1	No
Secondary	Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds	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)	Day 1	No