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Набор скоро начнётся NCT07612085

A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery

Без фазы С лечением Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

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: Biospecimen Collection, Electronic Health Record Review, Interview, Survey Administration.
Кому может быть актуально
Состояния в реестре: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. 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
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

Pilot Study on the Clinical Application of a Wearable Biosensor Patch for Non-Invasive Measurement of Biochemical and Blood Gas Analytes

Обзор

This clinical trial tests the feasibility and safety of a wearable biosensor patch for non-invasive monitoring for patients undergoing abdominal or chest surgery. Wearable biosensor patches have been developed by researchers to provide a non-invasive way to monitor substances that are normally checked using blood tests. This may reduce the need for frequent blood draws. The patches use gentle electrical stimulation to produce sweat and tiny built-in sensors to measure substances such as glucose, creatinine, and markers of inflammation, as well as oxygen and carbon dioxide levels. The wearable biosensor patch may be a feasible and safe way to monitor patients undergoing abdominal or chest surgery.

Подробное описание

PRIMARY OBJECTIVE:

I. To evaluate the feasibility of data collection using wearable postoperative biosensor patch.

SECONDARY OBJECTIVES:

I. To evaluate patient acceptability with using the wearable biosensor patch. II. To evaluate the safety of the wearable biosensor patch. III. To assess processes and resources needed to deploy the wearable biosensor patches postoperatively.

EXPLORATORY OBJECTIVES:

I. To explore the consistency of sweat analyte concentrations obtained using the wearable biosensor patch and a standard sweat collector.

II. To explore the accuracy of sweat-derived analyte concentrations relative to peripheral blood measurements (gold standard).

III. To explore the feasibility of intraoperative blood gas monitoring using a transcutaneous biosensor patch measuring oxygen (O₂) and carbon dioxide (CO₂).

IV. To explore the accuracy of O₂ and CO₂ concentrations obtained from the transcutaneous biosensor patch relative to paired intraoperative blood gas measurements (gold standard).

OUTLINE:

Patients have the wearable biosensor patch placed on the upper back or shoulder during surgery and wear it for the duration of the surgery to monitor oxygen and carbon dioxide levels. Starting the day after surgery, patients wear a biosensor patch on their wrist along with a sweat collecting chamber for 2-4 hours, up to twice daily, for up to 3 days post-operatively.

After completion of study intervention, patients may be followed up for up to 1 year.

Вмешательства

  • Процедура Biospecimen Collection
    Undergo sweat sample collection
  • Другое Electronic Health Record Review
    Ancillary studies
  • Другое Interview
    Ancillary studies
  • Другое Survey Administration
    Ancillary studies
  • Устройство Wearable Biosensor Patch
    Wear biosensor patch

Первичные конечные точки

  • Proportion of successful sweat collections (feasibility) [Срок оценки: Up to 1 year]
Вторичные конечные точки (3)
  • Acceptability of the intervention [Срок оценки: Up to 1 year]
  • Incidence of treatment related adverse events related to biosensor use [Срок оценки: Up to 1 year]
  • Processes and resources needed to deploy the wearable biosensor patches postoperatively [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Scheduled to have an elective abdominal or thoracic operation with anticipated post-operative hospitalization ≥ 3 days
  • Willingness to provide sweat samples, complete surveys, and permit review of medical records for research use
  • Ability to consent to the study procedures

Критерии исключения

  • Carbachol or pilocarpine allergy
  • Adhesive/tape allergy
  • Damaged or irritated skin on one or both wrists that prohibits placement of the biosensor and sweat collecting devices
  • Pregnant women
  • Children less than 18 years of age

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
Диагностика

Центры проведения

США · 1 центр
  • City of Hope Medical Center — Duarte

Идентификаторы

NCT: NCT07612085 · 25132 · NCI-2026-03601 · 25132 · P30CA033572

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗