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Search / Trial NCT06900738

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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Mar 21, 2025

Trial Information

Current as of April 23, 2025

Not yet recruiting

Keywords

Inflammatory Biomarker

ClinConnect 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 hemorheo...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  • 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
  • 3. Diagnosis of IBD (Crohn's disease or ulcerative colitis) or IBDU
  • 4. Hospitalized or ambulatory patients with active IBD defined as:
  • 1. HBI ≥ 5, or PMS score ≥3, and
  • 2. Faecal Calprotectin ≥200 μg/g or CRP \> 10 mg/ml, and
  • 3. Access to iOS or Android-based smartphone with internet access
  • 5. 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
  • Exclusion Criteria:
  • 1. Pregnancy
  • 2. Allergy to steel or elastomer/rubber
  • 3. Using a pacemaker, implantable cardiac defibrillator, neurostimulator, or other electronic medical equipment

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, , Belgium

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported