A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Hiatal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 12
- 主要终点
- Number of Subjects With a Hernia Recurrence Requiring Reoperation
研究概览
简要总结
Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived from the highly vascularized porcine liver. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. 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 hiatal 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
- •able and willing to sign the consent form and comply with all study visits and procedures
- •able to undergo elective laparoscopic hiatal hernia repair
- •free of cognitive or speech impairment
- •documented, symptomatic type II or III hernia ≥5cm in the axial/vertical dimension
- •commit to non-smoking for at least 4 weeks prior to procedure
排除标准
- •previous operation of the esophagus or stomach
- •sensitivity to porcine material
- •pregnant or plan to be pregnant within next 2 years
- •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
- •require emergent operation for acute gastric volvulus or strangulation
- •American Society of Anesthesiology (ASA) class 4 or greater
- •life expectancy of less than 2 years at the time of enrollment
- •associated gastrointestinal disease that requires extensive medical or surgical intervention that might interfere with the quality of life assessment (e.g. Crohn's disease)
- •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
Number of Subjects With a Hernia Recurrence Requiring Reoperation
时间窗: 2 years
Failure of the index hernia operation which requires another operative procedure to correct. Hernia recurrence was assessed with a barium upper gastrointestinal series or in some cases other imaging analysis to characterize the anatomy of the esophagus.
次要结局
未报告次要终点