Evaluating the Effective and Safe Use of Stream™ Platform

N/ANot Yet RecruitingNCT06522061

FluidAI Medical25 enrolled

Overview

The study aims to demonstrate the potential for at-home monitoring using Stream™ Platform, through simulated-use testing. Lay users, defined as subjects or nonprofessional caregivers, will be asked to operate Stream™ Platform. Safety, efficacy, and usability data will be collected to ensure that users are able to comply with prescribed device use. Additionally, clinical testing will be conducted to identify correlations between measurements from Stream™ Platform and standard laboratory, radiological, and clinical assessments used for leak detection as part of the current standard of care (SOC) that may be skipped if the subject is discharged early.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

User-Centered Design Anastomotic Leak Colorectal Surgery Artificial Intelligence

Interventions

Stream™ PlatformDEVICE

Stream™ Platform consists of 5 main components: Origin™, Delta™ Monitor, Stream™ Application, Accessory Calibration Syringe(s), and Stream™ Cart. Origin™ is an inline biosensor system that can be attached between an off-the-shelf drainage catheter and evacuator bag/bulb system and is designed to monitor real-time changes in drained effluent characteristics (specifically pH and electrical conductivity (EC)) for the early identification of postoperative complications. Origin™ requires daily calibration (via Accessory Calibration Syringe(s)) for optimal performance and accuracy of its sensors. The Stream Application is a mobile application for displaying and analyzing data collected continuously via Origin™. Stream™ Application is pre-installed on Android mobile devices (called Delta™ Monitor) that are supplied by FluidAI. Origin connects to Stream Application via Bluetooth. Mobile carts/mounts, denoted Stream™ Carts/Delta Mounts, will be used to house the Delta™ Monitor.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Evaluate if lay users can operate Stream Platform safely and effectively under healthcare providers supervision (simulated home use)

1. Statistical evaluation of the number of calibration errors encountered due to lay user error as reported by the healthcare providers. 2. Statistical evaluation of the number of calibration errors due to lay user errors that required intervention by the supervising healthcare provider to protect subject health and safety. 3. Occurrence of device associated adverse events including: i. Adverse Device Events (ADE) ii. Serious Adverse Device Events (SADE) iii. Unanticipated Serious Adverse Device Events (USADE) iv. Device Deficiencies