Normal Pressure Hydrocephalus (NPH) Registry
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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.
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Normal Pressure Hydrocephalus (NPH) Registry |
- 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 ]
- 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 ]
| 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) |
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 |
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.
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
Show 28 Study Locations| Study Chair: | Anthony Marmarou, Ph.D. | Virginia Commonwealth University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Michael Ward, Worldwide Director, Clinical Research, Codman & Shurtleff |
| ClinicalTrials.gov Identifier: | NCT00233701 History of Changes |
| Other Study ID Numbers: | NPH-US04-001 |
| Study First Received: | October 4, 2005 |
| Last Updated: | February 5, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Codman & Shurtleff:
|
NPH Hydrocephalus |
Additional relevant MeSH terms:
|
Hydrocephalus Hydrocephalus, Normal Pressure Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Intracranial Hypertension |
ClinicalTrials.gov processed this record on May 22, 2013