A Study on the Safety of Hakim Programmable Shunt System

Completed

• Conditions: Hydrocephalus

• Registration Number: NCT04285489
• Lead Sponsor: Integra LifeSciences Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-26
• Study Start: 2020-05-02
• Primary Completion: 2020-07-28
• Study Completion: 2020-07-28
• Results First Submitted: 2021-08-24
• Results First Submitted QC: 2021-09-20
• Results First Posted: 2021-09-21
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Non-infection Within One Year	1 year	Non-infection rate of a subject within one year

Trial Locations

Locations (5)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Guangzhou Women and Children Medical Center; 🇨🇳 Guangzhou, Guangdong, China

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Nanjing Brain Hospital Affiliated to Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China