Normal Pressure Hydrocephalus (NPH) Registry - Full Text View

Sponsors and Collaborators:	Codman & Shurtleff American Association of Neurological Surgeons
Information provided by:	Codman & Shurtleff
ClinicalTrials.gov Identifier:	NCT00233701

Purpose

The overall aim of the registry is to develop a longitudinal, observational database that is focused on adult patients with Normal Pressure Hydrocephalus (NPH) that can be used as a source of clinical information for individual surgeons, as well as a national data repository for scientific inquiry and publications.

Condition	Phase
Normal Pressure Hydrocephalus	Phase IV

MedlinePlus related topics: Hydrocephalus Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Normal Pressure Hydrocephalus (NPH) Registry

Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:

Database to describe the population of patients with NPH presenting for treatment (assessed at baseline/no safety assessment) [ Time Frame: End of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine frequency of the various treatments for NPH and the outcomes of those treatment (assessed during surgery and at follow-up/no safety assessment) [ Time Frame: End of trial ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	343
Study Start Date:	October 2004
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Detailed Description:

This is a prospective, multi-center, observational database to collect data on the characteristics, management practices, and patient outcomes of NPH patients. It will be offered to a geographically representative group of U.S. physicians who will enroll NPH patients. The physician makes his/her own clinical decisions; thus, the data captured provides current practice patterns related to diagnosis, management, and results. The registry may also assist physicians in patient follow-up and certain practice management tasks. The data collected will serve to inform the medical community on optimal care for this patient population

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

NPH patient who is a candidate for a shunt. Can not be under that age of 18, have a known contraindication for a shunt, or have an expected life span of less than 24 months.

Criteria

Inclusion Criteria:

Patient meets the diagnosis criteria for Normal Pressure Hydrocephalus
Patient is a candidate for a hydrocephalus shunt system, per the discretion of the investigator
Patient or legal representative has signed an informed consent form. Competency to sign the consent form will be left up to the discretion of the investigator

Exclusion Criteria:

Patient is under the age of 18 years
Patient has a known contraindication for a shunt
Patient has an expected life span of less than 24 months
Patient has an unwillingness or inability to return for required follow-up visits

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233701

Show 28 Study Locations

Sponsors and Collaborators

Codman & Shurtleff

American Association of Neurological Surgeons

Investigators

Study Chair:

Anthony Marmarou, Ph.D.

Virginia Commonwealth University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Codman & Shurtleff ( Michael Ward, Worldwide Director, Clinical Research )
Study ID Numbers:	NPH-US04-001
Study First Received:	October 4, 2005
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00233701 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Codman & Shurtleff:

NPH
Hydrocephalus

Study placed in the following topic categories:

Pseudotumor Cerebri
Infant, Newborn, Diseases
Central Nervous System Diseases
Hydrocephalus, Normal Pressure

Hydrocephalus
Brain Diseases
Intracranial Hypertension
Hypertension

Additional relevant MeSH terms:

Nervous System Diseases
Infant, Newborn, Diseases
Central Nervous System Diseases
Hydrocephalus, Normal Pressure

Hydrocephalus
Brain Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on May 07, 2009