NCT00280904

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
433

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

Geographic Reach
6 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

March 8, 2013

Completed
Last Updated

March 8, 2013

Status Verified

February 1, 2013

Enrollment Period

2.2 years

First QC Date

January 20, 2006

Results QC Date

November 17, 2010

Last Update Submit

February 5, 2013

Conditions

Hydrocephalus

Keywords

HydrocephalusShunt

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Shunt Infections

    Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.

    Implantation to Explant

Secondary Outcomes (1)

  • Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures

    April 2008

Interventions

Shunt catheterDEVICE

standard of care implantation of shunt (any brand). Subjects are followed for 90 days to obtain information about whether or not an infection occurred.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects of any age, gender and ethnicity, with hydrocephalus

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Children's memorial Hospital

Chicago, Illinois, 60614, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

Prince of Wales Hospital

Beijing, China

Location

Ua Shan Hospital

Shanghai, 200040, China

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

All India Insitute of Medical Sciences

New Delhi, 110029, India

Location

National Neuroscience Institute

Singapore, 308433, Singapore

Location

Related Publications (1)

  • Steinbok P, Milner R, Agrawal D, Farace E, Leung GK, Ng I, Tomita T, Wang E, Wang N, Wong GK, Zhou LF. A multicenter multinational registry for assessing ventriculoperitoneal shunt infections for hydrocephalus. Neurosurgery. 2010 Nov;67(5):1303-10. doi: 10.1227/NEU.0b013e3181f07e76.

    PMID: 20871445RESULT

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
J. Thomas Megerian
Organization
Codman & Shurtleff
jmegeri1@its.jnj.com
1-508-828-8274

Study Officials

  • Paul Steinbok, MBBS, FRCSC

    University of British Columbia

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2006

First Posted

January 24, 2006

Study Start

January 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

March 8, 2013

Results First Posted

March 8, 2013

Record last verified: 2013-02

Locations

HK(1)US(2)IN(1)SG(1)CN(2)CA(1)