NCT00233701

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
343

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2004

Longer than P75 for all trials

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 8, 2010

Status Verified

October 1, 2008

Enrollment Period

3.9 years

First QC Date

October 4, 2005

Last Update Submit

February 5, 2010

Conditions

Keywords

NPHHydrocephalus

Outcome Measures

Primary Outcomes (1)

  • Database to describe the population of patients with NPH presenting for treatment (assessed at baseline/no safety assessment)

    End of trial

Secondary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Boulder, Colorado, United States

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Unknown Facility

Jacksonville, Florida, United States

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Unknown Facility

Macon, Georgia, United States

Location

Unknown Facility

Boise, Idaho, United States

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Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Iowa City, Iowa, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Camden, New Jersey, United States

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Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Youngstown, Ohio, United States

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Unknown Facility

Midwest City, Oklahoma, United States

Location

Unknown Facility

Medford, Oregon, United States

Location

Unknown Facility

Portland, Oregon, United States

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Unknown Facility

Abington, Pennsylvania, United States

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Unknown Facility

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Johnson, Pennsylvania, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

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Unknown Facility

Kingsport, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

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Unknown Facility

Wichita Falls, Texas, United States

Location

Unknown Facility

Payson, Utah, United States

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Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Richmond, Virginia, 23298-0449, United States

Location

Unknown Facility

La Crosse, Wisconsin, United States

Location

Related Links

MeSH Terms

Conditions

Hydrocephalus, Normal PressureHydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Anthony Marmarou, Ph.D.

    Virginia Commonwealth University

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 6, 2005

Study Start

October 1, 2004

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 8, 2010

Record last verified: 2008-10

Locations