Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280904
Status:
COMPLETED
Last Update Posted:
2013-03-08
First Post:
2006-01-20
Brief Title:
A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
Sponsor:
Codman Shurtleff
Organization:
Codman Shurtleff
Study Overview
Official Title:
A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this Registry is to compare shuntcatheter-related infection rates among various shunt systems when used according to hospital standard of care to treat hydrocephalus
Detailed Description:
Clinical trials show that the majority of infections in shunt systems originate from bacterial contamination introduced at the time of surgery and most appear by 3-4 weeks post-operatively Protection must persist well beyond the surgical procedure to make certain that all contaminating bacteria are completely eradicated
Depending upon the institution shunt infection rates have been known to be as little as 1 to as much as 25 However two prospective trials that have been published from large databases with a consistent definition of infection have indicated an overall infection rate of approximately 10
This prospective non-randomized open-label Registry is designed to investigate and identify short-term shuntcatheter-related infection rates in ventriculoperitoneal shunt systems using various catheters during hospital standard of care treatment of Subjects with hydrocephalus Prospective Subjects will include those receiving shunts for the first time de novo and those with previously implanted shunts for whom catheter or total system replacements are required
This Registry will enroll 450 implanted Subjects of any age who meet all the inclusion criteria and none of the exclusion criteria and who provide signed Informed Consent to participate in this clinical Registry
Subjects will be followed for up to 90 days
Depending upon the institution shunt infection rates have been known to be as little as 1 to as much as 25 However two prospective trials that have been published from large databases with a consistent definition of infection have indicated an overall infection rate of approximately 10
This prospective non-randomized open-label Registry is designed to investigate and identify short-term shuntcatheter-related infection rates in ventriculoperitoneal shunt systems using various catheters during hospital standard of care treatment of Subjects with hydrocephalus Prospective Subjects will include those receiving shunts for the first time de novo and those with previously implanted shunts for whom catheter or total system replacements are required
This Registry will enroll 450 implanted Subjects of any age who meet all the inclusion criteria and none of the exclusion criteria and who provide signed Informed Consent to participate in this clinical Registry
Subjects will be followed for up to 90 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None