Economic Evaluation of Stream™ Platform

Economic Evaluation of Stream™ Platform for the Early Detection of Anastomotic Leakage After Gastrointestinal Surgery

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.

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