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

• Sponsor: Codman & Shurtleff (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00196196
• Collaborator: (none)
• Enrollment: 274
• Locations: 8
• Duration (Months): 25
• Patients Per Site: 34.3
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hydrocephalus; Normal Pressure Hydrocephalus	Device: Codman VPV System	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 274 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
• Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: Oct 1, 2006
• Actual Study Completion Date: Oct 1, 2006

Outcome Measures

Primary Outcome Measures

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

   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".

Secondary Outcome Measures

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

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States
2		Orlando	Florida	United States
3		Boston	Massachusetts	United States	02115
4		Newark	New Jersey	United States
5		New York	New York	United States
6		Cleveland	Ohio	United States
7		Portland	Oregon	United States
8		Richardson	Texas	United States

Sponsors and Collaborators

• Codman & Shurtleff

Investigators

• Study Director: J. Thomas Megerian, MD, Codman & Shurtleff

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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
• Other Study ID Numbers: VPV-US03-001
• First Posted: Sep 20, 2005
• Last Update Posted: May 28, 2012
• Last Verified: Feb 1, 2011

• Keywords provided by Codman & Shurtleff: Hydrocephalus; Codman Hakim Programmable Valve; Programmable Valve; Shunt System
• Additional relevant MeSH terms: Hydrocephalus; Hydrocephalus, Normal Pressure

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled between September 29, 2004 and October 13, 2006. Twelve (12) investigational sites within the US enrolled 274 Subjects.
Pre-assignment Detail	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.

Arm/Group Title	Codman VPV System
Arm/Group Description
Period Title: Overall Study
STARTED	274
COMPLETED	267
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Codman VPV System
Arm/Group Description
Overall Participants	267
Age (Count of Participants)
<=18 years	35 13.1%
Between 18 and 65 years	90 33.7%
>=65 years	142 53.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57 (26.1)
Sex: Female, Male (Count of Participants)
Female	137 51.3%
Male	130 48.7%
Region of Enrollment (participants) [Number]
United States	267 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading
Description	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".
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Codman VPV System
Arm/Group Description
Measure Participants	267
Number [Percentage of participants]	98.33 36.8%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Codman VPV System
Arm/Group Description
Measure Participants	267
Percentage of Agreement (exact match)	63.89
Percentage of Agreement in 1 step (+/- 10 mmH20)	96.11
Percentage of Agreement >2 steps (>20 mmH20)	1.67

Adverse Events

Arm/Group Title	Codman VPV System
Arm/Group Description
All Cause Mortality
	Codman VPV System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Codman VPV System
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Codman VPV System
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.