Status:
COMPLETED
A Study on the Safety of Hakim Programmable Shunt System
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Hydrocephalus
Eligibility:
All Genders
2-80 years
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. Dev...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 28 2020
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04285489
Start Date
May 2 2020
End Date
July 28 2020
Last Update
November 5 2021
Active Locations (5)
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1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053
2
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong, China
3
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
4
Nanjing Brain Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China