Normal Pressure Hydrocephalus (NPH) Registry

Normal Pressure Hydrocephalus Clinical Trial

Official title:

Normal Pressure Hydrocephalus (NPH) Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233701
• Other study ID #: NPH-US04-001
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2005
• Last updated: February 5, 2010
• Start date: October 2004
• Est. completion date: September 2008

Study information

• Verified date: October 2008
• Source: Codman & Shurtleff
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Normal Pressure Hydrocephalus

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Codman & Shurtleff	American Association of Neurological Surgeons

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Database to describe the population of patients with NPH presenting for treatment (assessed at baseline/no safety assessment)		End of trial	No
Secondary	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)		End of trial	No

External Links

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