Evaluating the Effective and Safe Use of Stream™ Platform

Launched by FLUIDAI MEDICAL · Jul 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new tool called the Stream™ Platform, which aims to help patients monitor their recovery at home after colorectal surgery. The researchers want to see if this tool is safe and effective, especially for detecting problems like leaks in the surgical connections (anastomosis) that can occur after surgery. Participants will use the Stream™ Platform, and their experiences will be reviewed to ensure it is easy to use and meets their needs. The study also aims to compare the measurements from the Stream™ Platform with traditional tests that doctors use to check for leaks, which could be particularly useful if patients are sent home early after surgery.

To be eligible for this trial, participants must be at least 18 years old and have had colorectal surgery that involved an anastomosis. They should also have a special drain in place after surgery and be willing to follow the study's requirements. It’s important to note that individuals who have already developed a leak or are planning to leave the hospital within three days post-surgery will not be included in the study. Participants will be guided on how to use the Stream™ Platform and will help researchers understand its usability and effectiveness in a home setting. Overall, this study could lead to better recovery monitoring for patients after colorectal surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years - male or female.
• • Subject/SDM understands and has voluntarily signed and dated Informed Consent Form (ICF).
• • Subject underwent colorectal surgery with anastomosis.
• • Subjects must be willing to comply with trial requirements.
• • Subject has a prophylactic abdominal/pelvic drain after colorectal surgery.
• Exclusion Criteria:
• • Subjects/caregiver is unwilling or unable to comply with the requirements of the protocol.
• • 24 hours or more have passed since the end of the subject's surgery and consent was not attained.
• • The subject had already developed an anastomotic leak at the time of screening and underwent surgery for treatment of the complication.
• • Plans that the subject will be discharged in less than 3 days post-surgery.
• • Subject has reported that they are pregnant.
• • Subject has a permanent end stoma.
• • Subject is delirious.
• • Subject has severe dementia.
• • Subject was involved in the planning and conduct of the clinical investigation.
• • Origin™ is not compatible with the drain used on the subject.
• • Subject and/or caregiver is/are not capable of conducting the calibrations for Stream™ Platform (this can be self-reported or determined by the CRC/HCP/other research staff).
• • The subject and/or caregiver is/are unable to understand the instructions provided for the management and calibration of Stream™ Platform (this can be self-reported or determined by the CRC/investigator/other research staff).