A Prospective, Multi-Center, Single Arm, Feasibility Study Using REBUILD Bioabsorbable™ for Closure of the Abdominal Wall After Oncologic Laparotomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
The REBUILD Study is a first-in-human evaluation of the safety and performance of REBUILD Bioabsorbable.
详细描述
REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures. In this study, REBUILD will be used in oncology patients undergoing an open, elective, intent-to-cure, laparotomy procedure. The study is a prospective, non-randomized, multi-center study designed to generate descriptive data about the use of REBUILD. The primary safety outcome is reported device-related adverse events. The primary performance outcome is the integrity of the abdominal wall over one year assessed by clinical examination of the abdomen. If available, CT studies performed within 12 months post-procedure will be used to confirm apposition of the medial border of the rectus muscles and integrity of the abdominal wall.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18-75 years of age
- •Patient is scheduled for oncologic, open, elective, intent-to-cure laparotomy
- •Patient is able to provide written informed consent
- •Patient is able and willing to comply with all study requirements
排除标准
- •Patient is scheduled for a palliative procedure
- •Patient has had previous failed surgical repair of a ventral or incisional hernia
- •Patient has a current infection at the intended surgical site
- •Patient is participating in a concurrent investigational medical device study
- •Patient is pregnant or planning on becoming pregnant during the study period
- •Patient has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to be compliant with post-operative visits.
研究组 & 干预措施
REBUILD
Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo oncologic laparotomy per the standard of care. The abdominal wall will be closed with REBUILD Bioabsorbable and suture of the surgeon's choice.
干预措施: REBUILD Bioabsorbable (Device)
结局指标
主要结局
Adverse Events
时间窗: 12 months
The number of device-related adverse events
Performance
时间窗: 12 months
The number of subjects with abdominal wall integrity at 3-, 6-, and 12-months post-surgery. Abdominal wall integrity will be assessed via clinical examination of the abdomen to identify a fascial defect, bulge, reducible palpable mass, or discomfort with a cough impulse. Standard of care CT or MR imaging that is performed within 12 months of the surgery will be evaluated to confirm apposition of the medial border of the rectus abdominis muscles and integrity of the abdominal wall.
次要结局
未报告次要终点