NCT02720042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
C. R. Bard15 个研究点 分布在 8 个国家目标入组 84 人开始时间: 2016年3月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 15
- 主要终点
- Number of Participants With One or More Surgical Site Occurrence Within 3 Months of Index Procedure
研究概览
简要总结
The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.
详细描述
Approximately 85 subjects, at approximately 12 sites across Europe will be enrolled and treated to study the use of Phasix™ Mesh. All treated subjects will be followed for 2 years post-implantation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be diagnosed with incisional midline hernia.
- •Subject has a VHWG Grade 3 hernia (as defined in the protocol).
- •Size of hernia ≥ 10 cm
- •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.
排除标准
- •Subject with > 4 previous repairs of the hernia under observation.
- •Body Mass Index (BMI) > 35 kg/m
- •The subject is on, or suspected to be placed on, chemotherapy medications during any part of the study.
- •The subject has peritonitis.
- •Known human immunodeficiency virus (HIV) infection (if documented in the subject's record).
- •The subject has cirrhosis of the liver and/or ascites.
- •Subject is American Society of Anesthesiology Class 4 or
- •Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
- •The hernia repair requires more than a single piece mesh (with adequate overlap beyond the margins of the defect on all sides).
- •Subject has intact permanent mesh adjacent to the current hernia to be repaired.
- •Subject's hernia repair requires intraabdominal mesh placement.
- •Surgical technique requires surgical bridge repair as the sole repair.
- •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.
- •Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding.
- •Subject has an alcohol/substance abuse problem or has had a relapse within 12 months of the screening visit.
- •Subject was involved in another interventional clinical study in the last 30 days prior to Informed Consent Form (ICF) signature.
- •Subject is part of the site personnel directly involved with this study.
- •Subject has a life expectancy of less than 2 years at the time of enrollment.
- •Subject has a known sensitivity to Phasix™ Mesh or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided).
结局指标
主要结局
Number of Participants With One or More Surgical Site Occurrence Within 3 Months of Index Procedure
时间窗: 3 Months
Proportions of subjects with Surgical Site Occurrences, which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 3 months. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: "The question \<Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?\> is answered with \<yes\>
次要结局
- Number of Participants With One or More Surgical Site Infection(24 Months)
- Mean Surgical Procedure Time of the Index Procedure as Measured From Incision to Closure(1 day)
- Number of Participants With a Hernia Recurrence(24 Months)
- Number of Participants Requiring Reoperation Due to Index Hernia Repair(24 Months)
- Mean Patient Reported Outcomes on Quality of Life Parameters as Measured by the Carolinas Comfort Scale (CCS) at 1, 3, 12 and 24 Months Post-Index Procedure(24 Months)
- Number of Participants With One or More Surgical Site Occurrence Within 24 Months of Index Procedure(24 Months)
- Mean Change in Pain Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure, as Measured by a 10.0 cm Visual Analogue Scale(24 Months)
- Mean Change in Quality of Life Assessments as Measured by the EQ-5D Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure(24 Months)
- Number of Participants With One or More Device-related Adverse Event(24 Months)
- Mean Time Until Participants Were Able to Return to Work(24 Months)
- Mean Length of Hospital Stay Related to Index Procedure(1 Month)
研究者
研究点 (15)
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