NL-OMON46922已完成不适用
A Post-Market, Prospective, Multi-Center, Single-Arm Clinical Investigation of Phasix Mesh for VHWG Grade 3 Midline Hernia Repair - Phasix mesh for the treatment of VHWG Grade 3 Midline Hernia Repair
Davol Inc.0 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •The subject must meet all of the criteria listed below to be enrolled in the study:
- •1. Subject must be 18 years of age or older.
- •2. Subject must be diagnosed with incisional midline hernia.
- •3. Subject has a VHWG Grade 3 hernia (as defined in 5.2.3).
- •4. Size of hernia * 10 cm2.
- •5. Subject must be willing to undergo a planned retro-rectus hernia repair (onlay allowed as an exception when retro-rectus placement cannot be achieved; using absorbable suture) with or without Component Separation Technique (CST).
- •6. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study*s provisions, and has duly signed the informed consent form (ICF). Subject agrees to comply with the protocol-mandated procedures and visits.
排除标准
- •The subject must be excluded from study enrollment if any of the following criteria are met:
- •1. Subject with > 4 previous repairs of the hernia under observation.
- •2. Body Mass Index (BMI) > 35 kg/m2.
- •3. The subject is on, or suspected to be placed on, chemotherapy medications during any part of the study.
- •4. The subject has peritonitis.
- •5. Known human immunodeficiency virus (HIV) infection (if documented in the subject*s record).
- •6. The subject has cirrhosis of the liver and/or ascites.
- •7. Subject is American Society of Anesthesiology Class 4 or 5.
- •8. Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
- •9. The hernia repair requires more than a single piece mesh (with adequate overlap beyond the margins of the defect on all sides).
- •10. Subject has intact permanent mesh adjacent to the current hernia to be repaired.
- •11. Subject*s hernia repair requires intraabdominal mesh placement.
- •12. Surgical technique requires surgical bridge repair as the sole repair.
- •13. Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.
- •14. Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding.
- •15. Subject has an alcohol/substance abuse problem or has had a relapse within 12 months of the screening visit.
- •16. Subject was involved in another interventional clinical study in the last 30 days prior to ICF signature.
- •17. Subject is part of the site personnel directly involved with this study.
- •18. Subject has a life expectancy of less than 2 years at the time of enrollment.
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