A Study on the Safety of Hakim Programmable Shunt System

  • STATUS
    Recruiting
  • participants needed
    130
  • sponsor
    Integra LifeSciences Corporation
Send
Updated on 16 February 2024
See if I qualify

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.

Details
Condition Hydrocephalus
Age 2years - 80years
Treatment Hakim Shunt Programmable System
Clinical Study IdentifierNCT04285489
SponsorIntegra LifeSciences Corporation
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.