A Study on the Safety of Hakim Programmable Shunt System

NCT04285489 | Completed Results

• 1 other identifier: C-HAKIM-001
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 5

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.

Conditions

Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Non-infection Within One Year

  Non-infection rate of a subject within one year

  1 year

Interventions

Hakim Shunt Programmable System DEVICE

patient accept Hakim Shunt Programmable System due to HCP

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (5)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Guangzhou Women and Children Medical Center

Guangzhou, Guangdong, China

Location

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

Wuhan, Hubei, China

Location

Nanjing Brain Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Hua Tang
• Organization: Integra LifeSciences (Shanghai) Co., Ltd.

hua.tang@integralife.com

0086 21 63179772

Study Officials

• Hua Tang, MD

  Integra LifeSciences Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: May 2, 2020
• Primary Completion: July 28, 2020
• Study Completion: July 28, 2020
• Last Updated: November 5, 2021
• Results First Posted: September 21, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)