A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus

Completed

Conditions studied: Hydrocephalus

In brief

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.

Key facts

Study ID

NCT00280904

Run by

Codman & Shurtleff

People needed

433

Starts

2006-01-01

Expected to finish

2008-04-01

Last updated by the study team

2013-03-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The Subject requires a surgical procedure to implant (de novo) a ventriculoperitoneal shunt or to replace an already implanted shunt catheter for the treatment of hydrocephalus.
• The Subject (family member/legal representative) has completed the Informed Consent process prior to enrollment into this Registry.
• The Subject (family member/legal representative) is willing to comply with the Registry protocol timelines \& requirements.

You may not qualify if…

• The Subject's planned shunt has distal drainage to the heart.
• The Subject has an active infection of the indwelling shunt system, cerebrospinal fluid or abdominal cavity.
• The Subject has ventriculitis, peritonitis or meningitis.
• The Subject has sepsis.
• The Subject has a history of poor wound healing.
• The Subject has symptoms pertaining to: a skin infection at or near the site of any incisions; an ear infection on either side; a respiratory tract infection; or a urinary tract infection that, in the Investigator's opinion is clinically significant and might compromise the outcome of this Registry.
• The Subject has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant
• The Subject has loculation(s) within the ventricular system.
• The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this Registry.
• The Subject is currently enrolled in another drug or device trial or has been previously entered in this trial.
• The Subject exhibits other difficulties, which would preclude follow-up for 90 days.
• The Subject is a prisoner.

Where it is running

• Children's memorial Hospital — Chicago, Illinois, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• British Columbia Children's Hospital — Vancouver, British Columbia, Canada
• Prince of Wales Hospital — Beijing, China
• Ua Shan Hospital — Shanghai, China
• Queen Mary Hospital — Hong Kong, Hong Kong
• All India Insitute of Medical Sciences — New Delhi, India
• National Neuroscience Institute — Singapore, Singapore

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.