Идёт набор NCT07194395

Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients

— Наблюдательное Hemodialysis Clinical Assessment

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: PatenSee System.
Кому может быть актуально: Состояния в реестре: Hemodialysis, Clinical Assessment. 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: США, Израиль
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective International Multicenter, Non-Interventional, Single Arm, Blinded Feasibility Study to Assess the Contactless Optical Monitoring of AV Access Using the PatenSee System in Dialysis Patients

Обзор

This is a prospective, non-interventional, single arm, international multicenter study in which up to 120 adult participants with kidney failure requiring regular hemodialysis through arteriovenous (AV) access (AV fistula or graft) will be recruited and evaluated using the PatenSee system. Data captured on the PatenSee system will be analyzed and evaluated against standard of care clinical monitoring of AV accesses.

Подробное описание

For eligible participants, a clinical exam of the AV access ("Look, Listen, Feel") per SOC will be done by a qualified site clinician/nurse, followed by an assessment of the AV access using the PatenSee system on a weekly basis for 6 weeks, and then biweekly up to 1 year from enrollment. Additional data regarding imaging and complications of the AV access will be collected. Clinical decisions, such as referrals for further investigation and management of the AV access will be based solely on standard clinical monitoring.

Вмешательства

Устройство PatenSee System
Contactless AV access monitoring device

Первичные конечные точки

Comparison of "Look" assessment with PatenSee's relevant output [Срок оценки: 6 weeks per patient]
Comparison of "Listen & Feel" assessments with PatenSee's relevant output [Срок оценки: 6 weeks per patient]

Вторичные конечные точки (3)

Functionality endpoint - Average time to conduct PatenSee scanning data capture [Срок оценки: Up to 12 months]
Functionality endpoint - Proportion (%) of participants on whom the PatenSee was used as planned [Срок оценки: Up to 12 months]
Functionality endpoint - Average number of weeks participants obtained PatenSee measurements [Срок оценки: Up to 12 months]

Критерии участия

Критерии включения

Male and female adult patient aged ≥18 years old
Patient has a non-reversible kidney failure that requires long-term hemodialysis
Patient has a functioning AV access (AVF/G) in the upper extremity
Patient is able and willing to provide consent by signing an EC/IRB approved informed consent form
Patient is willing and able to follow the requirements of the study

Критерии исключения

An active AV access infection
An AV access condition that will likely require revision, e.g., symptomatic steal syndrome
Expected to recover kidney function, receive a kidney transplant, transfer to peritoneal dialysis (PD) or transfer to non-study site during the study period.
Any reason per investigator's discretion for which the patient is not suitable for the study
Any medical or psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to adhere to study requirements
Previous participation in an interventional study within 30 days prior to study enrollment that may interfere with evaluation of the study endpoints
Female patient is pregnant or breastfeeding

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

Здоровые добровольцы: Нет