Evaluating the Effective and Safe Use of Stream™ Platform by a Lay User in a Simulated Environment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- FluidAI Medical
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Evaluate lay users' satisfaction through user feedback survey
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Masking Description
The investigators, care providers, participants, and outcome assessors will be blinded to the anastomotic leak risk-score generated by Stream Platform. This will ensure that subject care is not influenced by use of the device and postoperative monitoring is conducted as per the standard of care.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Intervention Arm
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.
All subjects recruited will take part in the evaluation of Stream™ Platform in a simulated home-use environment.
Intervention: Stream™ Platform (Device)
Outcomes
Primary Outcomes
Evaluate lay users' satisfaction through user feedback survey
Time Frame: Through study completion, an average of 6-months
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
Evaluate if lay users can operate Stream Platform safely and effectively under healthcare providers supervision (simulated home use)
Time Frame: Through study completion, an average of 6-months
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
Secondary Outcomes
- Identify correlations between measurements from Stream™ Platform and current standard of care (SOC).(Through study completion, an average of 6-months)
- 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.(Through study completion, an average of 6-months)
- Estimate the time taken by lay users to conduct calibration procedures(Through study completion, an average of 6-months)