Evaluating the Effective and Safe Use of Stream™ Platform
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFluidAI Medical
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Stream™ Platform
DeviceStream™ 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Through study completion, an average of 6-months2
Evaluate lay users' satisfaction through user feedback survey
Subject reported overall satisfaction with daily calibrations and overall device. The following parameters will be recorded on a scale of 1-5: 1. System Related Feedback * Overall feedback on Stream Platform * Overall feedback on Stream Application 2. Training Related Feedback * Overall feedback on the instructions provided by Stream Application * Overall feedback on the training material provided including but not limited to training video, infographic, etc. * Overall feedback on the in-person training conducted 3. Subject Comfort Assessment * Overall subject experience performing ADLs (Activities of Daily Living) while Stream Platform is in use. * Overall subject experience sleeping while Stream Platform is in use
Time frame
Through study completion, an average of 6-monthsSecondary outcomes
1
Utilize continuous pH and EC measurements collected prospectively using Stream™ Platform to supplement FluidAI's existing clinical model for early prediction of leakage after colorectal surgery.
Data collected will be used to supplement Stream™ Platform's existing clinical model for early prediction of leakage.
Time frame
Through study completion, an average of 6-months2
Identify correlations between measurements from Stream™ Platform and current standard of care (SOC).
Assess if any strong correlations exist between pH/EC measurement collected using FluidAI's Stream™ Platform and other diagnostic biomarkers for AL
Time frame
Through study completion, an average of 6-months3
Estimate the time taken by lay users to conduct calibration procedures
Quantify the average time taken by subjects/caregiver to conduct calibration in seconds as measured by the Stream™ Platform
Time frame
Through study completion, an average of 6-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: