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

NCT06900738 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-03-28

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Disease (IBD)
  • Ulcerative Colitis (UC)
  • Crohn Disease (CD)

Interventions

DEVICE

Inflammometer

Patients wear an inflammometer for Photoplethysmography measurements.

Sponsors & Collaborators

  • NimBio

    collaborator UNKNOWN

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-10-01
Completion
2026-10-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06900738 on ClinicalTrials.gov