Normal Pressure Hydrocephalus (NPH) Registry

Codman & Shurtleff343 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

343

Conditions

Normal Pressure Hydrocephalus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (28)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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