The REBUILD Trial: A Prospective, Multi-Center, Single Arm Study Using REBUILD for Abdominal Wall Closure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Efficacy Measure distance between the rectus abdominus muscles
研究概览
简要总结
The main objective of this clinical trial is to demonstrate the safety and efficacy of REBUILD when used to support abdominal wall closure after laparotomy. The main question it aims to answer are whether the device when used to support suture in abdominal wall closure safely maintains apposition of the abdominis rectus muscles within a pre-defined distance.
Participants will undergo standard of care laparotomy and the investigational device will be used to support the suture used to close the abdominal wall. Participants will have an MRI at 1-month after surgery to measure the distance between the abdominus rectus muscles.
详细描述
The REBUILD Trial (Protocol CTP-0002) is an investigational medical device study designed to demonstrate the efficacy and safety of REBUILD for abdominal wall closure (AWC). The primary evaluation period will include the first 30 days of follow up. After the 1-month endpoint evaluation period, additional follow-up at 3, 6, 12, and 24-months for post-market analysis and publication will be conducted. All adverse events will be collected and reported for the full duration of the study.
- Primary efficacy endpoint will be evaluated based on the measured distance between the rectus abdominis muscles (RAMs) by MRI at 1-month (Day 30 +14/-7 days) post-surgery (Day 0).
- Primary safety endpoint will be evaluated based on reported serious device-related adverse events through 1-month (Day 30 +14/-7 days) of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 22-80 years of age
- •Patient is undergoing a midline laparotomy procedure
- •Patient is able to provide written informed consent
- •Patient is able and willing to comply with all study requirements
排除标准
- •Patient has BMI > 40
- •Patients with available imaging measuring abdominal wall thickness < 5.7 mm or > 16.5 mm
- •Patient is scheduled for a palliative procedure or has a life expectancy of less than 12-months
- •Patient has mesh at the site of deployment
- •Patient has an ostomy within the planned midline closure site (4 cm either side of midline)
- •Patient has a CDC wound classification of Class IV
- •Patient has devitalized tissue present at the intended surgical site
- •Patient has any co-morbid conditions determined by the investigator to place them at a high risk of complications (e.g., severe cardiovascular disease, congestive heart failure NYHA Class III or IV, end-stage renal failure, liver cirrhosis, connective tissue disorder, poorly managed diabetes)
- •Patient is on any medication that the investigator determines creates a high risk for complications (e.g., antithrombotic, steroid, IV chemotherapy, immunosuppressive agent)
- •Patient has history of radiation therapy targeting the abdominal wall
- •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
结局指标
主要结局
Efficacy Measure distance between the rectus abdominus muscles
时间窗: Day 30 (+14/-7 days)
The primary efficacy endpoint is a maximum distance between the RAMs at 1-month after surgery \< 2.5 cm (binary outcome).
Serious device related adverse events
时间窗: Day 30 (+14/-7 days)
The primary safety endpoint is serious device-related adverse events through 1-month follow-up.
次要结局
未报告次要终点