A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 24
- 主要终点
- Performance - Sensitivity and Specificity of severe leak detection
研究概览
简要总结
Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis.
The clinical team is blinded to the leak detection of the xBar system.
详细描述
Study design: Pivotal, Prospective, Blinded, multi-center study. Study Population: This study will enroll approximately 190 eligible subjects undergoing scheduled colorectal surgery with anastomosis, without concomitant diversion.
xBar is an investigational device intended for post-op monitoring of patients undergoing GI surgery. The device is comprised of a surgical drain with embedded electrodes, connected to a small electronic device that records and relays data from the electrodes. The collected data is processed for early detection of complications.
Study description: The study is intended to validate the performance of the xBar system's anastomotic leak detection monitoring tool following colorectal resection with drain placement. During the index surgery the xBar device will be placed according to institution standard procedures and data recording will commence for a period of at least 3 days. Safety and complication detection performance will be evaluated retrospectively by comparing the diagnosis on a subject level done by the clinical team, who is blinded to xBar results, and the system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Investigators, clinical teams and subjects will be blinded to the outcomes provided by xBar system. Post operative monitoring will be as per SOC.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 22 years
- •Indication for sigmoid or rectal resection surgery.
- •Usage of drain during the surgery (to be confirmed during the surgery)
- •Willing and able to comply with the study follow up.
- •Able and agree to provide an informed consent.
排除标准
- •Contraindication for surgery and/or general anesthesia.
- •Pregnancy or lactation.
- •Planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery)
- •Known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
- •Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.
- •Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
- •Participation in another interventional study during the xBar system usage.
研究组 & 干预措施
Singel arm
All patients will be treated with the investigational device.
干预措施: xBar system (Diagnostic Test)
结局指标
主要结局
Performance - Sensitivity and Specificity of severe leak detection
时间窗: through study completion, an average of 1 year
Sensitivity and Specificity are non-inferior compared to Standard of care at POD 3
Safety - Severe leak rate - comparable to SOC.
时间窗: through study completion, an average of 1 year
Statistical evaluation of prevalence of anastomotic leaks in the study group compared to the prevalence present in the literature.
Safety
时间窗: through study completion, an average of 1 year
Lack of unanticipated serious adverse events related to the xBar system or xBar procedure during the study period.
Performance - successful xBar placement.
时间窗: through study completion, an average of 1 year
The device is working properly and records data in 90% of the cases or more.
次要结局
未报告次要终点