Analytical Validation of Stream™ Platform

Launched by FLUIDAI MEDICAL · Aug 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new technology called the Stream™ Platform, which is designed to help doctors monitor patients after gastrointestinal surgery. Specifically, the trial focuses on measuring the pH level, or acidity, of the fluid that drains from the abdomen after surgery. This information can help doctors detect any potential complications or infections early on, which is crucial for patient recovery. The Stream™ Platform uses a device called the Origin™ that attaches to standard surgical drains, allowing for real-time monitoring of this important parameter.

To participate in this trial, individuals must be at least 18 years old and have undergone either open or minimally invasive surgery that involved drainage from the abdomen. They should also be able to understand and sign a consent form to participate. Participants will have their drainage fluid samples collected and tested to ensure the Origin™ device is accurate and reliable. This study is important because it aims to improve how healthcare providers can monitor patients' recovery and quickly identify any issues that may arise after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years - male or female
• • Subject understands and has voluntarily signed and dated Informed Consent Form (ICF)
• • Subjects must be willing to comply with trial requirements
• • Subject has performed an open or laparoscopic surgery with abdominal/ pelvic drainage
• Exclusion Criteria:
• • Subject is expected to be discharged less than 8 hours post-surgery
• • Subject carries has a known infectious disease such as Hepatitis B or C, HIV, TB, infections caused by multi-drug resistant organisms, or known parasitic infections affecting the gastrointestinal tract
• • Involvement in the planning and conduct of the clinical investigation