Trial Outcomes & Findings for A Study on the Safety of Hakim Programmable Shunt System (NCT NCT04285489)
NCT ID: NCT04285489
Last Updated: 2021-11-05
Results Overview
Non-infection rate of a subject within one year
Recruitment status
COMPLETED
Target enrollment
130 participants
Primary outcome timeframe
1 year
Results posted on
2021-11-05
Participant Flow
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.
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.
Participant milestones
| Measure |
HAKIM Programmable Shunt System Arm
130 patients would be enrolled and adverse events would be collected for subjects enrolled within one year after the implantation of HAKIM Programmable Shunt system from April 01, 2017 to August 31, 2019, through case review or hospital database.
|
|---|---|
|
Overall Study
STARTED
|
130
|
|
Overall Study
COMPLETED
|
130
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study on the Safety of Hakim Programmable Shunt System
Baseline characteristics by cohort
| Measure |
HAKIM Programmable Shunt System Arm
n=130 Participants
One year' safety data of patients implanted HAKIM Programmable Shunt system from April 01, 2017 to August 31, 2019.
|
|---|---|
|
Age, Categorical
<=18 years
|
59 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.03 years
STANDARD_DEVIATION 24.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
130 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
130 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 130 participants implanted Hakim shunting system for 1 year
Non-infection rate of a subject within one year
Outcome measures
| Measure |
Treatment Arm, Single Arm Study
n=130 Participants
This study was designed to be single arm, multi-center, observational and retrospective. It is designed to collect information from actual clinical practice from the clinical records of patients in relation to the one-year clinical safety to the use of operation of HAKIM Programmable Shunt system.
|
|---|---|
|
Number of Participants With Non-infection Within One Year
|
5 Participants
|
Adverse Events
HAKIM Programmable Shunt System Arm
Serious events: 31 serious events
Other events: 9 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
HAKIM Programmable Shunt System Arm
n=130 participants at risk
Subject implanted HAKIM Programmable Shunt system for at least of one-year.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.5%
2/130 • Number of events 2 • within 1 year after investigated device implanted
|
|
Product Issues
Product problems
|
4.6%
6/130 • Number of events 6 • within 1 year after investigated device implanted
|
|
Respiratory, thoracic and mediastinal disorders
Intracranial infection
|
4.6%
6/130 • Number of events 6 • within 1 year after investigated device implanted
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.77%
1/130 • Number of events 1 • within 1 year after investigated device implanted
|
|
Nervous system disorders
Neurological disorders
|
5.4%
7/130 • Number of events 7 • within 1 year after investigated device implanted
|
|
Injury, poisoning and procedural complications
Injuries
|
4.6%
6/130 • Number of events 6 • within 1 year after investigated device implanted
|
|
Congenital, familial and genetic disorders
Craniosynostosis
|
0.77%
1/130 • Number of events 1 • within 1 year after investigated device implanted
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tumor
|
1.5%
2/130 • Number of events 2 • within 1 year after investigated device implanted
|
Other adverse events
| Measure |
HAKIM Programmable Shunt System Arm
n=130 participants at risk
Subject implanted HAKIM Programmable Shunt system for at least of one-year.
|
|---|---|
|
Product Issues
Product problems
|
6.9%
9/130 • Number of events 9 • within 1 year after investigated device implanted
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.4%
7/130 • Number of events 7 • within 1 year after investigated device implanted
|
|
Infections and infestations
Pneumonia
|
6.9%
9/130 • Number of events 9 • within 1 year after investigated device implanted
|
Additional Information
Dr. Hua Tang
Integra LifeSciences (Shanghai) Co., Ltd.
Phone: 0086 21 63179772
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60