Hydrocephalus
Conditions
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.
Interventions
DEVICEHakim Shunt Programmable System
patient accept Hakim Shunt Programmable System due to HCP
Sponsors
Integra LifeSciences Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Non-infection Within One Year | 1 year | Non-infection rate of a subject within one year |
Countries
China
Participant flow
Recruitment details
The study was conducted in Xuanwu Hospital, Capital Medical University, Guangzhou Women and Children Medical Center, West China Hospital Sichuan University, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Nanjing Brain Hospital. The first subject was enrolled in May 2, 2020, and all subjects were enrolled before Jul 1, 2020.
Pre-assignment details
Screened 140 patients, 130 of them were enrolled, including 71 adult patients and 59 minors (subject age below 18). 10 patients were screening failures for inclusion/exclusion criteria deviation.
Participants by arm
| Arm | Count |
|---|---|
| HAKIM Programmable Shunt System Arm One year' safety data of patients implanted HAKIM Programmable Shunt system from April 01, 2017 to August 31, 2019. | 130 |
| Total | 130 |
Baseline characteristics
| Characteristic | HAKIM Programmable Shunt System Arm |
|---|---|
| Age, Categorical <=18 years | 59 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants |
| Age, Continuous | 30.03 years STANDARD_DEVIATION 24.48 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 130 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 130 participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 130 |
| other Total, other adverse events | 9 / 130 |
| serious Total, serious adverse events | 31 / 130 |
Outcome results
Primary
Number of Participants With Non-infection Within One Year
Non-infection rate of a subject within one year
Time frame: 1 year
Population: 130 participants implanted Hakim shunting system for 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm, Single Arm Study | Number of Participants With Non-infection Within One Year | 5 Participants |