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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Codman & Shurtleff

ClinicalTrials.gov Identifier:

NCT00196196

First received: September 12, 2005

Last updated: May 22, 2012

Last verified: February 2011

History of Changes

Results First Received: November 4, 2008

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Hydrocephalus Normal Pressure Hydrocephalus
Intervention:	Device: Codman VPV System

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled between September 29, 2004 and October 13, 2006. Twelve (12) investigational sites within the US enrolled 274 Subjects.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 274 Subjects enrolled, 5 were determined to be ineligible - did not have hydrocephalus, a required condition per inclusion/exclusion criteria. Two (2) Subjects withdrew early. Overall, 267 Subjects were eligible for analysis.

Reporting Groups

	Description
Codman VPV System	No text entered.

Participant Flow: Overall Study

	Codman VPV System
STARTED	274
COMPLETED	267
NOT COMPLETED	7
Withdrawal by Subject	2
Did not have required condition (hydroce	5

Baseline Characteristics

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Reporting Groups

	Description
Codman VPV System	No text entered.

Baseline Measures

	Codman VPV System
Number of Participants [units: participants]	267
Age [units: participants]
<=18 years	35
Between 18 and 65 years	90
>=65 years	142
Age [units: years] Mean ± Standard Deviation	57 ± 26.1
Gender [units: participants]
Female	137
Male	130
Region of Enrollment [units: participants]
United States	267

Outcome Measures

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1. Primary:

Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading [ Time Frame: Day 1 ]

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2. Secondary:

Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds [ Time Frame: Day 1 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Jandira Ramos, MPH
Organization: Codman & Shurtleff, Inc.
phone: 508-828-3127
e-mail: jramos8@its.jnj.com

Publications:

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.

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.

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.

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.

Responsible Party:	Codman & Shurtleff
ClinicalTrials.gov Identifier:	NCT00196196 History of Changes
Other Study ID Numbers:	VPV-US03-001
Study First Received:	September 12, 2005
Results First Received:	November 4, 2008
Last Updated:	May 22, 2012
Health Authority:	United States: Institutional Review Board

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