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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hakim Shunt Programmable System | Device | patient accept Hakim Shunt Programmable System due to HCP |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-infection Within One Year | Non-infection rate of a subject within one year | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with an implanted Hakim catheter due to Hydrocephalus (HCP)
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| Name | Affiliation | Role |
|---|---|---|
| Hua Tang, MD | Integra LifeSciences Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | 100053 | China | ||
| Guangzhou Women and Children Medical Center |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
130 enrolled subjects were included into PPS.
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| ID | Title | Description |
|---|---|---|
| BG000 | HAKIM Programmable Shunt System Arm | One year' safety data of patients implanted HAKIM Programmable Shunt system from April 01, 2017 to August 31, 2019. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Non-infection Within One Year | Non-infection rate of a subject within one year | 130 participants implanted Hakim shunting system for 1 year | Posted | Count of Participants | Participants | 1 year |
|
|
within 1 year after investigated device implanted
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HAKIM Programmable Shunt System Arm | Subject implanted HAKIM Programmable Shunt system for at least of one-year. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Product problems | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hua Tang | Integra LifeSciences (Shanghai) Co., Ltd. | 0086 21 63179772 | 8029 | hua.tang@integralife.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2019 | Sep 18, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Guangzhou |
| Guangdong |
| China |
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China |
| Nanjing Brain Hospital Affiliated to Nanjing Medical University | Nanjing | Jiangsu | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 4 |
| 130 |
| 31 |
| 130 |
| 9 |
| 130 |
| Product problems | Product Issues | Systematic Assessment |
|
| Intracranial infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Neurological disorders | Nervous system disorders | Systematic Assessment |
|
| Injuries | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Craniosynostosis | Congenital, familial and genetic disorders | Systematic Assessment |
|
| tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
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