Condition or disease | Intervention/treatment | Phase |
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Replacement and Extension of Connective Tissue Structure in Neurosurgery | Device: Lyoplant® Onlay/DURAFORM™ Dural Graft Implant | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Multi-center, Randomized, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Lyoplant Onlay in Repairing Cerebral Dura Mater |
Actual Study Start Date : | July 24, 2018 |
Estimated Primary Completion Date : | August 30, 2019 |
Estimated Study Completion Date : | August 30, 2019 |
Arm | Intervention/treatment |
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Experimental: Lyoplant® Onlay
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
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Device: Lyoplant® Onlay/DURAFORM™ Dural Graft Implant
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.
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Active Comparator: DURAFORM™ Dural Graft Implant
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
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Device: Lyoplant® Onlay/DURAFORM™ Dural Graft Implant
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.
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Related to lesions:
Exclusion Criteria:
Contact: Zongjie Duan | +86 10 57632775 | zongjie.duan@bbraun.com | |
Contact: Sally Jin |
China, Zhejiang | |
The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting |
Hangzhou, Zhejiang, China, 310009 | |
Contact: Jianmin Zhang 86 571 87784715 z2sjwk@sina.com |
Tracking Information | |||||
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First Submitted Date ICMJE | May 14, 2019 | ||||
First Posted Date ICMJE | May 15, 2019 | ||||
Last Update Posted Date | May 15, 2019 | ||||
Actual Study Start Date ICMJE | July 24, 2018 | ||||
Estimated Primary Completion Date | August 30, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Surgical successful rate without leakage of cerebrospinal fluid (CSF) 90 days [ Time Frame: 90days ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | The Efficacy and Safety of Lyoplant® Onlay in Repairing Cerebral Dura Mater | ||||
Official Title ICMJE | A Prospective, Multi-center, Randomized, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Lyoplant Onlay in Repairing Cerebral Dura Mater | ||||
Brief Summary | 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Replacement and Extension of Connective Tissue Structure in Neurosurgery | ||||
Intervention ICMJE | Device: Lyoplant® Onlay/DURAFORM™ Dural Graft Implant
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.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
240 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | August 30, 2019 | ||||
Estimated Primary Completion Date | August 30, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Related to lesions:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03951272 | ||||
Other Study ID Numbers ICMJE | AAG-G-H-1715 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | B. Braun Medical International Trading Company Ltd. | ||||
Study Sponsor ICMJE | B. Braun Medical International Trading Company Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | B. Braun Medical International Trading Company Ltd. | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |