NCT02408458撤回不适用
A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Ventral Hernia Repair
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 8
- 主要终点
- Hernia recurrence requiring surgical intervention
研究概览
简要总结
This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.
详细描述
Miromatrix Medical Inc. has developed a new biologic mesh, called MIROMESH®. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. Miromatrix Biologic Mesh is a non cross-linked, acellular surgical mesh that is derived from the highly vascularized porcine liver. This study will serve to provide clinicians with high-quality clinical data in order to provide them with a higher degree of confidence when selecting MIROMESH for ventral hernia repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 18 and 80 years old on the day of study enrollment
- •ventral or incisional hernia greater than 9 cm2 for which the physician anticipates ability to achieve midline fascia closure following a retro-rectus repair/component separation
- •hernia classified as CDC class 1 or 2 preoperatively
- •able and willing to sign the consent form and comply with all study visits and procedures
- •commit to non-smoking for at least 4 weeks prior to procedure
排除标准
- •sensitivity to porcine material
- •scheduled for a concomitant procedure of a wound classified as other than clean
- •immunocompromised or at risk of immunosuppression (i.e. be HIV positive, be experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as determined by the Investigator
- •A1C level ≥10.0
- •participating in another clinical study
- •cirrhosis, and/or ascites
- •diagnosed with a collagen vascular disorder
- •American Society of Anesthesiology (ASA) Class 4 or 5
- •allergic to tetracycline or kanacmycin
- •life expectancy of less than 2 years at the time of enrollment
- •any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements
结局指标
主要结局
Hernia recurrence requiring surgical intervention
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (8)
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