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NOT YET RECRUITING
NCT06900738
NA

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

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-10-01

Completion Date

2026-10-01

Last Updated

2025-03-28

Healthy Volunteers

No

Interventions

DEVICE

Inflammometer

Patients wear an inflammometer for Photoplethysmography measurements.

Locations (1)

University Hospital Leuven

Leuven, Belgium