NCT01981044终止不适用
A SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair
Sofregen Medical, Inc.2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2013年9月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Rate of Hernia Recurrence
研究概览
简要总结
Prospective, multi center, single arm, clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support in ventral hernia repair.
详细描述
Prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. Subjects will be followed for 24 months post SERI placement during index hernia repair surgery. Study visits will occur at screening, from SERI implantation through hospital discharge and then post SERI implantation at month(s) 1, 3, 6, 12, 18, and 24 for all enrolled subjects.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following are requirements for entry into the study. The subject MUST:
- •Be ≥ 18 years of age
- •Be diagnosed with a ventral hernia as defined as:
- •Midline Ventral Hernia AND
- •Defect(s) MUST meet the following criteria:
- •contained within an anatomical area of ≤ 150 cm2
- •not be longer than 8cm in any direction
- •size must have a total sum ≤ 64 cm2
- •Be eligible for retro-rectus placement of SERI
- •Have a BMI < 40
排除标准
- •The following are criteria for exclusion from participating in the study. The subject must
- •Be > 70 years of age
- •Have prior occurrence of ventral hernia or parastomal hernia
- •Have a presence of a stoma or have a perforated bowel
- •Have any documented disease which is clinically known to impact wound healing, including Chronic Obstructive Pulmonary Disease (COPD), and Congestive Heart Failure (CHF), with the exception of controlled diabetes
- •Have documented history of diabetes with an A1C of ≥ 8 at time of pre-operative visit
- •Have documented autoimmune disease, an immune deficiency, or be on immunosuppressive drugs with the exception of steroids for:
- •prophylactic one-time-use administered peri-operatively
- •inhaled general use
- •topical administration
- •Have documented collagen-vascular, connective tissue, bleeding disorders and/or on anticoagulation therapy, with the exception of baby aspirin for one week prior to SERI placement
- •Have documented cancer < 6 months prior to surgery or chemotherapy treatment < 6 months prior to surgery
- •Have documented history of abdominal radiation therapy or is expected to have abdominal radiation therapy during the conduct of this study
- •Have documented history of liver disease and/or renal failure requiring dialysis
- •Have documented history of a previous wound infection at the surgical site or have an active infection at the time of surgery
- •Have had prior surgery with synthetic and/or biologic mesh in the abdominal, chest or pelvic area
- •Have documented allergy to silk
- •Have documented UTI at the time of surgery
- •Have smoked within 6 weeks of surgery and have a positive nicotine test at time of preoperative visit
- •Have a concurrent procedure intra-operatively (with the exception of lysis of abdominal adhesions)
- •Require intra-peritoneal or bridging placement of the soft tissue support device or require component separation at time of surgery
- •Have surgical circumstances that are contraindicated for use of SERI™ Surgical Scaffold per the supplied package insert
- •Have a concomitant unrelated condition of abdominal/chest wall/skin that would require a surgical intervention during the follow-up period
- •Have documented alcohol and/or substance abuse problem at time of pre-operative visit
- •Be pregnant, lactating, or if of childbearing potential, be unwilling to use contraceptive methods and avoid pregnancy throughout the study
结局指标
主要结局
Rate of Hernia Recurrence
时间窗: 24 months postoperatively
Hernia recurrence at 24 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
次要结局
未报告次要终点
研究者
研究点 (2)
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