Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT00280904
Status:
COMPLETED
Last Update Posted:
2013-03-08
First Post:
2006-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
Sponsor:
Codman & Shurtleff
Organization:
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 shunt/catheter-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 shunt/catheter-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 shunt/catheter-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:
False
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?: