Clinical trial NCT06522061: Evaluating the Effective and Safe Use of Stream™ Platform
Official title: Evaluating the Effective and Safe Use of Stream™ Platform by a Lay User in a Simulated Environment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: User-Centered Design
Anastomotic Leak
Colorectal Surgery
Artificial Intelligence
Keywords: Anastomotic Leak
Artificial Intelligence
Colorectal Surgery
ERAS
Stream Platform
Lead sponsor: FluidAI Medical
Sponsor class: INDUSTRY
First posted: 2024-07-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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).

Primary outcomes:
measure: Evaluate if lay users can operate Stream Platform safely and effectively under healthcare providers supervision (simulated home use)
timeFrame: Through study completion, an average of 6-months
measure: Evaluate lay users' satisfaction through user feedback survey
timeFrame: Through study completion, an average of 6-months
Secondary outcomes:
measure: 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.
timeFrame: Through study completion, an average of 6-months
measure: Identify correlations between measurements from Stream™ Platform and current standard of care (SOC).
timeFrame: Through study completion, an average of 6-months
measure: Estimate the time taken by lay users to conduct calibration procedures
timeFrame: Through study completion, an average of 6-months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital - Providence Healthcare (PHC)
state: British Columbia
Study officials:
References: