A Study on the Safety of Hakim Programmable Shunt System

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Brief Title

A Study on the Safety of Hakim Programmable Shunt System

Official Title

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

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.
    



Study Type

Observational


Primary Outcome

Number of Participants With Non-infection Within One Year


Condition

Hydrocephalus

Intervention

Hakim Shunt Programmable System


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

130

Start Date

May 2, 2020

Completion Date

July 28, 2020

Primary Completion Date

July 28, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. 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.

          2. Subject had an indication suitable to use Hakim Shunt Programmable System.

          3. Subject received a Hakim Shunt Programmable System at least one year ago.

        Exclusion Criteria:

          1. Subject didn't have an indication suitable to use the product.

          2. Subject was known to be allergic to a component or ingredient of the product to be
             implanted, including silicone tubing and other components.

          3. 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.

          4. Subject was simultaneously implanted with another shunt system different from Hakim
             Shunt Programmable System.

          5. Subject had a contraindication of the shunt operation.

          6. Subject had uncorrected coagulopathy or any bleeding disorder.
      

Gender

All

Ages

2 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Hua Tang, MD, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04285489

Organization ID

C-HAKIM-001


Responsible Party

Sponsor

Study Sponsor

Integra LifeSciences Corporation


Study Sponsor

Hua Tang, MD, Study Director, Integra LifeSciences Corporation


Verification Date

November 2021