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Набор скоро начнётся NCT07047664

KERMIT: Sweat Patch for Early Kidney Disease Detection

Без фазы С лечением Chronic Kidney Disease (CKD)

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: KERMIT dermal patch, KERMIT dermal patch.
Кому может быть актуально
Состояния в реестре: Chronic Kidney Disease (CKD). 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
Список центров уточняется — проверьте первичный протокол.
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

Kidney Disease Sweat Sensor Patch for Early Diagnosis and Remote MonIToring

Обзор

Chronic kidney disease (CKD) affects over 10% of the global population, leading to significant morbidity, mortality, and economic burden. Early detection is crucial for preventing disease progression and complications; however, awareness and diagnosis of CKD remain alarmingly low. Current methods rely on blood or urine analysis, which are invasive and require specialized facilities. The KERMIT patch aims to address this gap by providing a wearable lab-on-a-chip device capable of measuring key biomarkers from sweat non-invasively. This innovation has the potential to revolutionize CKD diagnosis, particularly in remote or underserved areas. The KERMIT patch integrates functional printed biosensors, a high-frequency electrochemical microchip, and a sustainable microfluidic system. Sensors are fabricated using carbon inks and 2D materials, enabling immunodetection and non-enzymatic sensing of creatinine, urea, and cystatin C. Preliminary tests evaluated detection limits, skin compatibility, and carbon footprint.

Вмешательства

  • Устройство KERMIT dermal patch
    The KERMIT patch is a non-invasive, wearable device designed to collect sweat and measure concentrations of kidney function biomarkers, including creatinine, urea, and cystatin C. The patch integrates printed biosensors and a microfluidic system for electrochemical detection. It is applied to the skin for a short duration (typically \<1 hour), with pilocarpine stimulation. This study evaluates the patch's performance in differentiating between CKD patients with reduced versus preserved renal fun
  • Устройство KERMIT dermal patch
    The KERMIT patch is a non-invasive, wearable device designed to collect sweat and measure concentrations of kidney function biomarkers, including creatinine, urea, and cystatin C. The patch integrates printed biosensors and a microfluidic system for electrochemical detection. It is applied to the skin for a short duration (typically \<1 hour), with pilocarpine stimulation. This study evaluates the patch's performance in differentiating between CKD patients with reduced versus preserved renal fun

Первичные конечные точки

  • Creatinine concentration in sweat [Срок оценки: Day 1 (includes screening, device application, and sample analysis)]
  • Urea concentration in sweat [Срок оценки: Day 1 (includes screening, device application, and sample analysis)]
  • Incidence of adverse events related to the wearable device [Срок оценки: Day 1 (up to 1 hour post-device removal)]

Критерии участия

Критерии включения

Adults aged ≥18 years with stable CKD, defined as:

  • eGFR < 60 mL/min/1.73 m², or
  • eGFR ≥ 60 mL/min/1.73 m² with documented evidence of kidney damage (persistent albuminuria, structural abnormalities on imaging or histology, or genetic kidney disease).

Критерии исключения

  • Any signs of dermal infections, open wounds, or skin irritation.
  • Significant variations in eGFR in the last two months, defined as any absolute change (either increase or decline) in eGFR of >10 mL/min/1.73m2 ;
  • Patients with a functioning kidney graft;
  • Patients receiving immunosuppression treatment;
  • Patients with kidney stones;
  • Patients with uncontrolled hypertension (a systolic blood pressure (SBP) >150 mmHg and/or diastolic blood pressure (DBP) >90 mmHg with measurements taken under standardized conditions (e.g after a 5-minute seated rest, using validated equipment);
  • Patients receiving drugs reported to affect serum levels of creatinine and cystatin-c without affecting kidney function (i.e. cimetidine, trimethoprim, and fibrates);
  • Known allergy to pilocarpine,
  • Glaucoma;
  • Patients with metal implants;
  • Pregnancy;
  • Active malignancy;
  • Low life expectancy (<6 months) according to investigators judgement

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07047664 · KERMIT-UOI-01 · Horizon Europe EIC programme

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗