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OpenTrials
Completed

NCT Number: NCT00233701

Normal Pressure Hydrocephalus (NPH) Registry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Phoenix, Arizona, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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)

    Time frame: End of trial

Sponsors and collaborators

Lead sponsor

Codman & Shurtleff

Industry

Collaborators

  • American Association of Neurological Surgeons

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Oct 6, 2005
Registry last updated
Feb 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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