A Multi-center, Retrospective Registry Study on the Safety of Hakim Programmable Shunt System

Integra LifeSciences Corporation5 sites in 1 country130 target enrollmentMay 2, 2020

ConditionsHydrocephalus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hydrocephalus
Sponsor: Integra LifeSciences Corporation
Enrollment: 130
Locations: 5
Primary Endpoint: Number of Participants With Non-infection Within One Year
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aimed to collect safety information from subjects implanted with a shunt system (trade name: Hakim Shunt Programmable System) produced by Codman & Shurtleff, Inc. of the United States. Device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.

Registry

clinicaltrials.gov

Start Date

May 2, 2020

End Date

July 28, 2020

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Integra LifeSciences Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The informed consent was exempted by the Ethics Committee of a research center. Either a subject or his/her legal representative signed the informed consent form (ICF) prior to enrollment.
•Subject had an indication suitable to use Hakim Shunt Programmable System.
•Subject received a Hakim Shunt Programmable System at least one year ago.

Exclusion Criteria

•Subject didn't have an indication suitable to use the product.
•Subject was known to be allergic to a component or ingredient of the product to be implanted, including silicone tubing and other components.
•According to the comprehensive judgment of an investigator, subject had an infection of the implant site when the shunt system was implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection.
•Subject was simultaneously implanted with another shunt system different from Hakim Shunt Programmable System.
•Subject had a contraindication of the shunt operation.
•Subject had uncorrected coagulopathy or any bleeding disorder.