Overview
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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