A Study on the Safety of Hakim Programmable Shunt System

Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04285489
• Other study ID #: C-HAKIM-001
• Status: Completed
• Start date: May 2, 2020
• Est. completion date: July 28, 2020

Study information

• Verified date: November 2021
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 28, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

Device:
• Hakim Shunt Programmable System
patient accept Hakim Shunt Programmable System due to HCP

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Guangzhou Women and Children Medical Center	Guangzhou	Guangdong
China	Nanjing Brain Hospital Affiliated to Nanjing Medical University	Nanjing	Jiangsu
China	Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Non-infection Within One Year	Non-infection rate of a subject within one year	1 year