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

Purpose

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	Intervention	Phase
Hydrocephalus Normal Pressure Hydrocephalus	Device: Codman VPV System	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.

Resource links provided by NLM:

MedlinePlus related topics: Hydrocephalus X-Rays

Genetic and Rare Diseases Information Center resources: Hydrocephalus

U.S. FDA Resources

Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:

Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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)


Enrollment:	274
Study Start Date:	September 2004
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Valve Positioning Verification (VPV) System

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


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196196

Locations


United States, Arizona

Phoenix, Arizona, United States
United States, Florida

Orlando, Florida, United States
United States, Massachusetts

Boston, Massachusetts, United States, 02115
United States, New Jersey

Newark, New Jersey, United States
United States, New York

New York, New York, United States
United States, Ohio

Cleveland, Ohio, United States
United States, Oregon

Portland, Oregon, United States
United States, Texas

Richardson, Texas, United States

Sponsors and Collaborators

Codman & Shurtleff

Investigators


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

More Information

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

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

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

Keywords provided by Codman & Shurtleff:


Hydrocephalus Codman Hakim Programmable Valve Programmable Valve Shunt System

Additional relevant MeSH terms:


Hydrocephalus, Normal Pressure Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases

ClinicalTrials.gov processed this record on September 29, 2016