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Not yet recruiting NCT06522061

Evaluating the Effective and Safe Use of Stream™ Platform

No phase Interventional User-Centered Design Anastomotic Leak Colorectal Surgery Artificial Intelligence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stream™ Platform.
Who it may be relevant to
Registry conditions: User-Centered Design, Anastomotic Leak, Colorectal Surgery, Artificial Intelligence. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluating the Effective and Safe Use of Stream™ Platform by a Lay User in a Simulated Environment

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.

Interventions

  • Device Stream™ Platform
    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 calibr

Primary outcome measures

  • 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]
  • Evaluate lay users' satisfaction through user feedback survey [Time frame: Through study completion, an average of 6-months]
Secondary outcome measures (3)
  • 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. [Time frame: Through study completion, an average of 6-months]
  • Identify correlations between measurements from Stream™ Platform and current standard of care (SOC). [Time frame: Through study completion, an average of 6-months]
  • Estimate the time taken by lay users to conduct calibration procedures [Time frame: Through study completion, an average of 6-months]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Canada · 1 center
  • St. Paul's Hospital - Providence Healthcare (PHC) — Vancouver

Identifiers

NCT: NCT06522061 · CLS0009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗