Economic Evaluation of Stream™ Platform (CostAL)

FluidAI Medical

Status and phase: Active, not recruiting; Phase 3

Conditions: Anastomotic Leak

Treatments: Device: Stream™ Platform with Risk Score Omitted; Device: Stream™ Platform

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05994625

CLS0007

Details and patient eligibility

About

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.

Enrollment: 215 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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215 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Device: Stream™ Platform

Control Group

Sham Comparator group

Description:

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.

Treatment:

Device: Stream™ Platform with Risk Score Omitted