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

Primary Purpose

Hydrocephalus, Normal Pressure Hydrocephalus

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Codman VPV System
Sponsored by
Codman & Shurtleff
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hydrocephalus focused on measuring Hydrocephalus, Codman Hakim Programmable Valve, Programmable Valve, Shunt System

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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)

Full Information

First Posted
September 12, 2005
Last Updated
May 22, 2012
Sponsor
Codman & Shurtleff
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1. Study Identification

Unique Protocol Identification Number
NCT00196196
Brief Title
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

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Codman & Shurtleff

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocephalus, Normal Pressure Hydrocephalus
Keywords
Hydrocephalus, Codman Hakim Programmable Valve, Programmable Valve, Shunt System

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Codman VPV System
Intervention Description
Valve Positioning Verification (VPV) System
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Thomas Megerian, MD
Organizational Affiliation
Codman & Shurtleff
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Newark
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Richardson
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10448649
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.
Results Reference
background
Citation
Petrie A, Sabin C. Medical Statistics at a Glance. Blackwell Science Ltd: 90-91
Results Reference
background
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
Results Reference
background
PubMed Identifier
10598708
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.
Results Reference
background
PubMed Identifier
9870057
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.
Results Reference
background
PubMed Identifier
10839253
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.
Results Reference
background

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

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