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Набор скоро начнётся NCT06522061

Evaluating the Effective and Safe Use of Stream™ Platform

Без фазы С лечением User-Centered Design Anastomotic Leak Colorectal Surgery Artificial Intelligence

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Stream™ Platform.
Кому может быть актуально
Состояния в реестре: User-Centered Design, Anastomotic Leak, Colorectal Surgery, Artificial Intelligence. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Устройство 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

Первичные конечные точки

  • Evaluate if lay users can operate Stream Platform safely and effectively under healthcare providers supervision (simulated home use) [Срок оценки: Through study completion, an average of 6-months]
  • Evaluate lay users' satisfaction through user feedback survey [Срок оценки: Through study completion, an average of 6-months]
Вторичные конечные точки (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. [Срок оценки: Through study completion, an average of 6-months]
  • Identify correlations between measurements from Stream™ Platform and current standard of care (SOC). [Срок оценки: Through study completion, an average of 6-months]
  • Estimate the time taken by lay users to conduct calibration procedures [Срок оценки: Through study completion, an average of 6-months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

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

Идентификаторы

NCT: NCT06522061 · CLS0009

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗