Evaluating the Effective and Safe Use of Stream™ Platform (Home-Stream)

FluidAI Medical

Status: Not yet enrolling

Conditions: User-Centered Design; Artificial Intelligence; Colorectal Surgery; Anastomotic Leak

Treatments: Device: Stream™ Platform

Study type: Interventional

Funder types: Industry

Identifiers

NCT06522061

CLS0009

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Intervention Arm

Experimental group

Description:

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.

Treatment:

Device: Stream™ Platform