Inflammatory Bowel Disease (IBD)VERSATILENCT06900738
A Study to Evaluate Non-invasive Measurements of the Inflammatory Status in Patients with IBD
A study testing Inflammometer in people with Inflammatory Bowel Disease (IBD) and Ulcerative Colitis (UC), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC), Crohn Disease (CD)
- What is being tested?
- Inflammometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Allergy to steel or elastomer/rubber
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, or other electronic medical equipment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stefan Delen, Dr contact
Belgium1 site
University Hospital Leuven
Leuven, 3000
Marc Ferrante, Prof Dr, 016342845 ext. +32, marc.ferrante@uzleuven.be
About this study
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.
Read the detailed description
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
- Being tested
- Inflammometer
- Keywords
- inflammatory biomarker
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InflammometerDevice
Also called inflammatory biomarkers, Photoplethysmography
Patients wear an inflammometer for Photoplethysmography measurements.
| Study group | Role | What they receive |
|---|---|---|
| IBD patients with inflammometer | Other | blood samples, stool samples, questionnaires and inflammometer measurements Receives: Device: Inflammometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of the the PPG signal with any dynamic biomarker
Correlation of the inflammatory dynamics (trajectory) as measured by NimBio's technology with any dynamic biomarker in the IBD patient population
Measured: 6 months
Secondary outcomes (9)
Correlation of the PPG signal with the patient inflammatory status
Correlation of the inflammatory dynamics as measured by NimBio's technology with the patient inflammatory status as defined by any dynamic biomarker as compared to each individual biomarker in the overall IBD patient population.
Measured: 6 months
Classification of the inflammatory status based on the PPG signal
Classification of the inflammatory status as inflamed vs non-inflamed based on NimBio's technology as defined by increase of 1.5-fold over the upper normal limit
Measured: 6 months
Correlation of the inflammatory trajectory with the patient's inflammatory status
Correlation of the inflammatory trajectory as defined by NimBio's technology with the patient's inflammatory status as assessed by HBI, PRO-2, PMS and SCCAI
Measured: 6 months
Classification of the inflammatory status compared to the clinical disease activity
Classification of the inflammatory status as inflamed vs non-inflamed based on NimBio's technology compared to the clinical disease activity measured by disease activity questionnaires (where inflammation is defined as HBI> 5 and PMS>3).
Measured: 6 months
Time of NimBio's indication of a change in the inflammatory status
The time of NimBio's indication of a change in the inflammatory status compared with the time of change in the clinical disease score or a physician instructed treatment modification
Measured: 6 months
Assessment of physiological parameters
Assessment of physiological parameters such as pulse rate, as measured by non-invasive measurements
Measured: 6 months
Assessment of patient satisfaction
Assessment of patient satisfaction about the wearable with PREM questionnaire
Measured: 6 months
Assessment of the correlation between the inflammatory status and disease activity
Assessment of the correlation between the inflammatory status determined by NimBio's technology and disease activity as measured by endoscopy
Measured: 6 months
The effect of the integration of physiological parameters into NimBio's algorithm
The effect of the integration of physiological parameters such as pulse rate into NimBio's algorithm as compared to at least one inflammatory biomarker reflecting the patient's inflammatory status
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- NimBio
- Responsible party
- Principal investigator, Marc Ferrante, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900738
- Sponsor's protocol ID
- VERSATILE
- Acronym
- VERSATILE
- Status last verified
- Feb 2025
- First submitted
- 14 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Non-invasive Measurements of the Inflammatory Status in Patients with IBD
- ClinicalTrials.gov ID
- NCT06900738
- Acronym / sponsor ID
- VERSATILE / VERSATILE
- Keywords
- inflammatory biomarker
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- NimBio
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD patients with inflammometer | Other | Device: Inflammometerblood samples, stool samples, questionnaires and inflammometer measurements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Allergy to steel or elastomer/rubber
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, or other electronic medical equipment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InflammometerAlso: inflammatory biomarkers, PhotoplethysmographyPatients wear an inflammometer for Photoplethysmography measurements. | Device | IBD patients with inflammometer |
Primary outcome
Correlation of the the PPG signal with any dynamic biomarker
Time frame: 6 months
Correlation of the inflammatory dynamics (trajectory) as measured by NimBio's technology with any dynamic biomarker in the IBD patient population
9 secondary outcomes
Correlation of the PPG signal with the patient inflammatory status
Time frame: 6 months
Classification of the inflammatory status based on the PPG signal
Time frame: 6 months
Correlation of the inflammatory trajectory with the patient's inflammatory status
Time frame: 6 months
Classification of the inflammatory status compared to the clinical disease activity
Time frame: 6 months
Time of NimBio's indication of a change in the inflammatory status
Time frame: 6 months
Assessment of physiological parameters
Time frame: 6 months
Assessment of patient satisfaction
Time frame: 6 months
Assessment of the correlation between the inflammatory status and disease activity
Time frame: 6 months
The effect of the integration of physiological parameters into NimBio's algorithm
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Delen, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inflammometer in people with Inflammatory Bowel Disease (IBD) and Ulcerative Colitis (UC), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Ferrante, Prof Dr (016342845 ext. +32, marc.ferrante@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of the the PPG signal with any dynamic biomarker (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.