A Study to Evaluate Non-invasive Measurements of the Inflammatory Status in Patients with IBD

Обзор

Patients with IBD, including both Crohn's disease and ulcerative colitis, require accurate monitoring of intestinal inflammation for optimal follow-up and treatment. Traditional markers like C-reactive protein (CRP) and faecal calprotectin are useful but are either invasive or disliked by patients and a proper continuous monitoring is not feasible with fragmented biomarker information. The NimBio technology provides support for the clinicians who are managing IBD patients' care based on a wearable technology that allows tracking responsiveness of blood flow properties (also called hemorheology) to inflammatory processes. NimBio's technology analyses blood flow properties using photoplethysmography (PPG), an optical signal, which detects blood flow changes in the microvascular bed of tissues. The PPG signal is obtained from a commercially available wearable (bracelet) which is convenient for the patients. Based on the impact of inflammation on parameters influencing hemorheology (mainly blood vessel stiffness, blood viscosity and red blood cell aggregation) and the fact that the PPG signal mirrors blood flow characteristics, PPG measurements are associated with changes in inflammatory biomarkers and therefore correlate with disease activity. This offers a possibility for continuous, non-invasive monitoring of inflammation. The study aims to further validate the NimBio Inflammometer and its value for monitoring inflammatory changes and dynamics in patients with IBD at the University Hospitals Leuven.

Подробное описание

Patients with IBD, including both Crohn's disease and ulcerative colitis, require accurate monitoring of intestinal inflammation for optimal follow-up and treatment. Traditional markers like C-reactive protein (CRP) and faecal calprotectin are useful but are either invasive or disliked by patients and a proper continuous monitoring is not feasible with fragmented biomarker information.

The NimBio technology provides support for the clinicians who are managing IBD patients' care based on a wearable technology that allows tracking responsiveness of blood flow properties (also called hemorheology) to inflammatory processes. NimBio's technology analyses blood flow properties using photoplethysmography (PPG), an optical signal, which detects blood flow changes in the microvascular bed of tissues. The PPG signal is obtained from a commercially available wearable (bracelet) which is convenient for the patients. Based on the impact of inflammation on parameters influencing hemorheology (mainly blood vessel stiffness, blood viscosity and red blood cell aggregation) and the fact that the PPG signal mirrors blood flow characteristics, PPG measurements are associated with changes in inflammatory biomarkers and therefore correlate with disease activity.

This offers a possibility for continuous, non-invasive monitoring of inflammation. The study aims to further validate the NimBio Inflammometer and its value for monitoring inflammatory changes and dynamics in patients with IBD at the University Hospitals Leuven

Вмешательства

• Устройство Inflammometer
  Patients wear an inflammometer for Photoplethysmography measurements.

Первичные конечные точки

• Correlation of the the PPG signal with any dynamic biomarker [Срок оценки: 6 months]

Вторичные конечные точки (9)

• Correlation of the PPG signal with the patient inflammatory status [Срок оценки: 6 months]
• Classification of the inflammatory status based on the PPG signal [Срок оценки: 6 months]
• Correlation of the inflammatory trajectory with the patient's inflammatory status [Срок оценки: 6 months]
• Classification of the inflammatory status compared to the clinical disease activity [Срок оценки: 6 months]
• Time of NimBio's indication of a change in the inflammatory status [Срок оценки: 6 months]
• Assessment of physiological parameters [Срок оценки: 6 months]
• Assessment of patient satisfaction [Срок оценки: 6 months]
• Assessment of the correlation between the inflammatory status and disease activity [Срок оценки: 6 months]
• The effect of the integration of physiological parameters into NimBio's algorithm [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• At least 18 years of age at the time of signing the Informed Consent Form (ICF)
• Diagnosis of IBD (Crohn's disease or ulcerative colitis) or IBDU
• Hospitalized or ambulatory patients with active IBD defined as:

• HBI ≥ 5, or PMS score ≥3, and
• Faecal Calprotectin ≥200 μg/g or CRP > 10 mg/ml, and
• Access to iOS or Android-based smartphone with internet access
• Ambulatory patients would be recruited to the study with a gender ratio that will not deviate from a 40:60 ratio in favor of either gender

Критерии исключения

• Pregnancy
• Allergy to steel or elastomer/rubber
• Using a pacemaker, implantable cardiac defibrillator, neurostimulator, or other electronic medical equipment

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

Бельгия · 1 центр

• University Hospital Leuven — Leuven

Идентификаторы

NCT: NCT06900738 · VERSATILE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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