COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 288
- 试验地点
- 20
- 主要终点
- To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month
研究概览
简要总结
The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.
详细描述
The proposed study is a post marketing study intended to gather and record additional data to further evaluate the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis.
The study objective is to evaluate the performance of the ColonRing™ in the creation of a circular anastomosis in colorectal procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 is ≥ 18 years old.
- •Subject is planned to undergo a non-emergency (i.e., elective) operation with the creation of an anastomosis using the ColonRing™.
- •Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
排除标准
- •Subject has a known allergy to nickel.
- •Subject is planned to undergo an emergency procedure or has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel,carcinomatosis.
- •Subject has participated in another clinical study which may affect this study's outcomes within the last 30 days.
- •Subject's ASA (American Society of Anesthesiology) score 4 or
- •Subject has a concurrent or previous invasive pelvic malignancy.
- •Subject has a systemic or incapacitating disease.
- •Subject has extensive local disease in the pelvis.
- •Subject requires more than one anastomosis during the surgery.
- •Women who are known to be pregnant.
结局指标
主要结局
To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month
时间窗: Approx. 1 year
Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.
Device Related Leak Rate up to 30 Days Post op
时间窗: 30 days post op
Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.
次要结局
- Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure.(30 days post op)