Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohorts
研究概览
简要总结
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
详细描述
The study is intended to evaluate the effect of xBar utilization on clinical outcomes during recovery from colorectal surgery. During the study, patients in the intervention group admitted for low anterior resection surgery will have xBar placed during their index surgery. The overall morbidity, healthcare utilization costs, and stoma utilization of the intervention group will be compared to those of the historical control group, consisting of patients meeting the same inclusion/exclusion criteria of the patients in the intervention group.
The xBar system, classified as a non-significant risk device in the pivotal study, is designed as an integrated platform for post-operative monitoring, built to fit into the existing clinical workflow without altering the standard surgical protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Interventional Cohort
- •Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer
- •Expected anastomosis within 10 cm from the anal verge
- •Usage of drain during the surgery (to be confirmed during the surgery)
- •Willing and able to comply with the study follow up and able and agree to provide informed consent.
- •Historical Cohort
- •Adults aged ≥21 years at the time of surgery.
- •Underwent a low anterior resection (LAR) for malignant colorectal disease.
- •Documented colorectal anastomosis located <10cm from the anal verge, or documented tumor <10cm from the anal verge. Complete documentation for the index hospitalization and for the required 12-month follow-up period, or up to stoma take down procedure whichever came first.
排除标准
- •Interventional Cohort
- •Subjects with benign disease
- •Contraindication for surgery and/or general anesthesia.
- •Known pregnancy or lactation.
- •Subjects receiving prophylactic stoma formation during index surgery (to be confirmed intraoperatively)
- •Known electronic devices 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. Historical Cohort
- •1. LAR performed for benign or non-oncologic indications (e.g., diverticulitis, inflammatory bowel disease, non-malignant strictures, fistula).
研究组 & 干预措施
Historical Control Cohort
A de-identified historical cohort consisting of a matched population that underwent surgical procedures during 2023. Historical data will include subject demographics, initial diagnosis, index surgery details, tumor location, comorbidities, length of stay (LOS), and readmission rates following the index colorectal surgery.
Interventional Cohort
The xBar drain will be placed during the elective low anterior resection, which will be performed according to each medical center's standard surgical procedures. Following placement, the xBar system will continuously collect measurements until drain removal.
干预措施: xBar™ System (Device)
结局指标
主要结局
Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohorts
时间窗: At the time points of 30 and 90 days following index surgery
Non-inferiority of the mean Modified Comprehensive Complication Index (MCCI) of the modified intent-to-treat (mITT) population at 30 days following the index surgery, compared with the MCCI of the matched historical cohort.
Primary Safety Endpoint - No Unexpected Serious Adverse Device Events within the Intent to Treat population during the study period ( up to 365 days following index surgery)
时间窗: from the date of index surgery up to 365 days following the index surgery
Lack of unanticipated serious adverse events related to the xBar system or xBar procedure during the study period ( up to 365 days from the index surgery)
次要结局
- Number of Stoma-Free patients during the study follow up(Time points 30 days, 90 days, 6 months and 12 months following the index surgery)
- Sensitivity and specificity of xBar outcome(As from Visit 0 (Day of Surgery -drain placement) through the discharge visits (drain removal as per routine practice), anticipated average 3 days.)
- 1. Comparison of MCCI Comorbidity Index (between study cohorts) 2. Number of Stome-Free patients during the study follow up 3. Sensitivity and specificity of xBar outcome(At timepoints of 30, 90 ,180 and 365 days following the index surgery)