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Completed

NCT Number: NCT04285489

A Study on the Safety of Hakim Programmable Shunt System

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.

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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

2 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hakim Shunt Programmable System

Device

patient accept Hakim Shunt Programmable System due to HCP

Primary outcomes

  1. Number of Participants With Non-infection Within One Year

    Time frame: 1 year

    Non-infection rate of a subject within one year

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2020
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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