A Prospective, Multicenter, Single-arm, Post Market Study to Evaluate the Safety and Performance of the Signia™ Circular Stapler With Tri-Staple™ Technology in Elective Open or Minimally Invasive Left-sided Colon, Sigmoid, and Rectal Resections (SECURE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 137
- 试验地点
- 12
- 主要终点
- Incidence of anastomotic leak
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.
详细描述
The primary objective of this study is to evaluate the safety and performance of the Signia™ circular stapler, for the creation of anastomoses assessed by the incidence of anastomotic leak within 30 days following use in subjects undergoing left sided colon, sigmoid, or rectal resections.
The secondary objectives of this study are to assess safety and performance outcomes within 90 days following the use of the Signia™ circular stapler in subjects undergoing left sided colon, sigmoid, or rectal resections.
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
- •Preoperative Inclusion Criteria:
- •Subject is competent and willing to provide documented informed consent to participate in this clinical study
- •Subject is intended to undergo an elective left sided colon/colorectal procedure where a creation of an anastomosis will be completed with the Signia™ circular stapler
- •Subject is ≥ 18 years of age at time of consent
- •Preoperative
排除标准
- •Subject is unable or unwilling to comply with the study requirements or follow-up schedule
- •Subject with ASA classification ≥ IV
- •Subject is pregnant (as determined by standard site practices)
- •The procedure is an emergency procedure
- •The procedure is a revision/reoperation for the same indication
- •The subject has a documented confounding medical condition which in the opinion of the investigator, will not be appropriate for the study, or the subject has an estimated life expectancy of less than 6 months
- •Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study
- •Subject will undergo multiple synchronous colon resections
- •Subject with a bleeding disorder or is undergoing anticoagulant treatment that has not been reversed (anticoagulant prophylaxis prescribed as part of the surgical protocol is allowed)
- •Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure
- •Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure)
- •Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure)
- •Any subject undergoing an ileal-anal pouch anastomosis surgery
- •Intraoperative Exclusion Criteria
- •Anastomosis not attempted with the Signia™ circular stapler
- •Any subject for which the device is intended to be used outside the instructions for use (IFU)
研究组 & 干预措施
Left sided colon/colorectal procedure with creation of an anastomosis
single arm study, no control arm
干预措施: Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system) (Device)
结局指标
主要结局
Incidence of anastomotic leak
时间窗: within 30 days, +/- 14 days
Incidence of anastomotic leak following the use of the Signia™ circular stapler used in subjects undergoing left sided colon, sigmoid, or rectal resections. Diagnosis will be confirmed postoperatively by computed tomography (CT) imaging (with or without a contrast agent), or postoperatively via direct verification during re-operation. Anastomotic leakage confirmed to have occurred at a staple line other than the colon/colorectal anastomosis created with the Signia™ circular stapler will not impact the primary endpoint analysis.
次要结局
- Incidence of anastomotic leaks(within 90 days, +/- 14 days)
- Clinical significance of anastomotic leaks(within 90 days, +/- 14 days)
- Incidence of a Signia™ circular stapler and accessory components device deficiency (DD)(Day 0 (day of surgery))
- Incidence of anastomotic bleeding(within 30 and 90 days, +/- 14 days)
- Incidence of device-related adverse events(within 90 days, +/- 14 days)
- Length of hospital stay(discharge (post-surgery up to 90 days, +/- 14 days))
- Incidence of re-operation or surgical intervention(within 90 days, +/- 14 days)