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Objective of this clinical trial is to compare the safety and efficacy of Mianfengxing Kexishou Yingmo Bupian(Lyoplant® Onlay) and Yingmo Bupianfor dural repair.270 subjects will be enrolled for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lyoplant® Onlay | Experimental | All the model including 2.5cm×2.5cm, 5.0cm×5.0cm,2.5cm×7.5cm,7.5cm×7.5cm,10.0cm×12.5cm will be used in this study |
|
| DURAFORM™ Dural Graft Implant | Active Comparator | All the model including 2.54cm×2.54cm,5.08cm×5.08cm, 2.54cm×7.62cm, 7.62cm×7.62cm,10.16cm×12.70cm will be used in this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyoplant® Onlay/DURAFORM™ Dural Graft Implant | Device | Lyoplant® Onlay will be used as a dura substitute for the repair of the duramater.The DURAFORM™ Dural Graft Implant will be used in the procedures where the repair or substitution of the patient's dura mater is needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical successful rate without leakage of cerebrospinal fluid (CSF) 90 days | Surgical successful rate without leakage of cerebrospinal fluid (CSF) 90 days after the surgery (Confirmed by radiological image evaluation and physical examination on surgical site). Each patient firstly undergoes an initial CT and if necessary, MRI will be used to further examine the volume of CSF leakage. | 90days |
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Inclusion Criteria:
Related to lesions:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zongjie Duan | Contact | +86 10 57632775 | zongjie.duan@bbraun.com | |
| Sally Jin | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 17, 2022 | |
| Reset | Aug 30, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 17, 2022 | Aug 30, 2023 |
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