A Study on the Safety of Hakim Programmable Shunt System

A Multi-center, Retrospective Registry 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.

Study Overview

• Status: Completed
• Conditions: Hydrocephalus
• Intervention / Treatment: Device: Hakim Shunt Programmable System

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital, Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangzhou Women and Children Medical Center
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing Brain Hospital Affiliated to Nanjing Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with an implanted Hakim catheter due to Hydrocephalus (HCP)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Non-infection Within One Year	Non-infection rate of a subject within one year	1 year

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Study Director: Hua Tang, MD, Integra LifeSciences Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2020
• Primary Completion (Actual): July 28, 2020
• Study Completion (Actual): July 28, 2020

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: C-HAKIM-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No