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A Study on the Safety of Hakim Programmable Shunt System

NCT ID: NCT04285489

Last Updated: 2021-11-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-02

Study Completion Date

2020-07-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hydrocephalus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Hakim Shunt Programmable System

patient accept Hakim Shunt Programmable System due to HCP

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Integra LifeSciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hua Tang, MD

Role: STUDY_DIRECTOR

Integra LifeSciences Corporation

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Guangzhou Women and Children Medical Center

Guangzhou, Guangdong, China

Site Status

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Nanjing Brain Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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C-HAKIM-001

Identifier Type: -

Identifier Source: org_study_id