Economic Evaluation of Stream™ Platform for the Early Detection of Anastomotic Leakage After Gastrointestinal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 215
- 试验地点
- 4
- 主要终点
- Does Stream™ Platform integrate well with the existing clinical workflow (3)?
研究概览
简要总结
This Economic Evaluation study is a multi-center, two-arm, non-randomized, interventional trial. The purpose of this study is to evaluate the economic and patient outcomes of using the Stream™ Platform for early detection of anastomotic leakage after gastrointestinal surgery. The trial will track patient outcomes and healthcare costs in two groups: the intervention group, where the Stream platform is deployed, and the control group, before the integration of the Stream™ Platform. The data collected from both groups will be compared to assess the impact of implementing the Stream™ Platform and early leak detection on overall patient outcomes and healthcare costs.This trial will include hepatobiliary, colorectal, and trauma/acute care patient populations.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years - Male or Female
- •Subject understands and has voluntarily signed and dated the informed consent form (ICF).
- •Subjects must be willing to comply with trial requirements
- •Subject has performed an open or laparoscopic surgery with peritoneal or pelvic drainage
排除标准
- •Subject is pregnant
- •Subject will be discharged < 8 hours post-surgery
- •24 or more have passed since the end of the subject's surgery
- •Involvement in the planning and conduct of the clinical investigation
- •Subject is allergic to contrast medium
- •Participation in another investigational drug or device study which would interfere with the endpoints of this study
- •Device does not attach to drain used on the subject
研究组 & 干预措施
Intervention Group
Stream™ Platform will be attached to the abdominal/pelvic drains of the patients enrolled in this group. The platform will conduct continuous pH and electrical conductivity measurements of the abdominal drain fluid. The continuous pH and electrical conductivity measurements will be used to calculate a Risk Score that will be provided to surgeons. Surgeons will employ the Risk Score produced alongside the standard of care for guiding the postoperative care of patients.
干预措施: Stream™ Platform (Device)
Control Group
Stream™ Platform will be attached to the abdominal/pelvic drains of the patients enrolled in this group. The platform will conduct continuous pH and electrical conductivity measurements of the abdominal drain fluid. However, Stream™ Platform will not generate a Risk Score and therefore, will not impact the postoperative care of patients. All procedures will be conducted as per the standard of care or institutional policies. Stream™ Platform will only be used for observation in the Control group.
干预措施: Stream™ Platform with Risk Score Omitted (Device)
结局指标
主要结局
Does Stream™ Platform integrate well with the existing clinical workflow (3)?
时间窗: Through study completion, an average of 1 year
Quantify the overall reported satisfaction score of the CRC/delegate through surveys.
Does Stream™ Platform reduce the cost of care for anastomotic leak patients in colorectal, hepatobiliary, and trauma and acute care surgeries (1)?
时间窗: Upon study completion (12 months)
Quantify the average number of tests and procedures performed to detect anastomotic leakage before and after the implementation of Stream™ Platform.
Does Stream™ Platform integrate well with the existing clinical workflow (1)?
时间窗: Through study completion, an average of 1 year
Quantify average time spent by clinical research coordinator (CRC)/delegate interacting with Stream™ Platform (during attachment, daily calibration, and detachment) in minutes
Number of Subjects with Device Related Adverse Events
时间窗: Upon study completion (12 months)
An adverse event assessment will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events.
Does Stream™ Platform integrate well with the existing clinical workflow (2)?
时间窗: Through study completion, an average of 1 year
Observe overall compliance to Instructions for use though quantification of the number of daily calibrations completed
Does Stream™ Platform reduce the cost of care for anastomotic leak patients in colorectal, hepatobiliary, and trauma and acute care surgeries (2)?
时间窗: Upon study completion (12 months)
Quantify the average patient cost/cost of hospitalization and by-department cost (log of all billed items including medications, laboratory investigations, diagnostic/radiology investigations, hospital length of stay, ICU admission, re-admission within 30 days after discharge, time of discharge and therapeutic services) for colorectal, HPB, and trauma and acute care patients before and after the implementation of Stream™ Platform.
次要结局
- Does Stream™ Platform allow for earlier postoperative anastomotic leak detection in colorectal, HPB, and trauma and acute care surgeries compared to clinical judgment/laboratory assessment (2)?(Upon study completion (12 months))
- Does Stream™ Platform allow for earlier postoperative anastomotic leak detection in colorectal, HPB, and trauma and acute care surgeries compared to clinical judgment/laboratory assessment (1)?(Upon study completion (12 months))
- Does Stream™ Platform reduce the need for non-conservative management and hospital re-admission that is associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries (1)?(Upon study completion (12 months))
- Does Stream™ Platform reduce the need for non-conservative management and hospital re-admission that is associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries (2)?(Upon study completion (12 months))
- Does Stream™ Platform reduce adverse events that are associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries?(Upon study completion (12 months))