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| Name | Class |
|---|---|
| University of Turku | OTHER |
| Imec | INDUSTRY |
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This prospective, single-center clinical investigation conducted in France will evaluate two non-invasive investigational devices (HEMI and SPG-NINOX) designed to assess microcirculation in adults. The study will include 165 participants divided into five groups (33 per group): healthy volunteers, patients with hypertension without chronic kidney disease (CKD), patients with type 2 diabetes without CKD, patients with moderate CKD, and patients with severe CKD. The primary objective is to compare baseline small vessel pressure measured with the HEMI (Multi-spectral optical system for microcirculation hemodynamics) device across groups in order to identify microvascular alterations associated with cardiometabolic and renal disease. Secondary objectives include assessment of microvascular responses after post-ischemic hyperemia, evaluation of SPG-derived (Speckle plethysmography) small vessel flow and volume parameters, comparison with reference vascular measurements (including SphygmoCor and ultra-high frequency ultrasound), and evaluation of feasibility, acceptability, and measurement reproducibility. Participation is non-randomized, based on participants' pre-existing clinical condition, and study procedures are non-invasive with an expected visit duration of approximately 60 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | Adults without known hypertension, type 2 diabetes, or chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit. |
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| Hypertension Without Chronic Kidney Disease | Experimental | Adults with hypertension and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit. |
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| Type 2 Diabetes Mellitus Without Chronic Kidney Disease | Experimental | Adults with type 2 diabetes mellitus and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit. |
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| Moderate Chronic Kidney Disease | Experimental | Adults with moderate chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit. |
|
| Severe Chronic Kidney Disease |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEMI device | Device | Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel pressure at baseline. Measurements are performed during a single study visit under standardized conditions. In predefined subgroups, additional measurements may be performed after post-ischemic hyperemia and for reproducibility assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| HEMI-derived small vessel pressure at baseline | Small vessel pressure derived from the HEMI non-invasive investigational device under standardized resting conditions at baseline. The primary analysis compares values across the five study groups. | Baseline (single study visit, approximately 60 minutes) |
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Inclusion Criteria:
Common Inclusion Criteria:
Common Exclusion Criteria:
Exclusion Criteria:
Hypertension Group
Inclusion: Prior diagnosis of arterial hypertension
Stable cardiovascular treatment in the previous 1 month
Exclusion:
Inclusion:
Prior diagnosis of type 2 diabetes
Stable cardiovascular treatment in the previous 1 month
Exclusion:
Inclusion:
Moderate CKD (eGFR between 30 and 60 mL/min) (CKD-EPI)
Patients scheduled for arterial stiffness assessment as part of routine care
Stable cardiovascular treatment in the previous 1 month
Exclusion:
No specific exclusion criteria beyond common exclusions Severe CKD Group
Inclusion:
Exclusion: No specific exclusion criteria beyond common exclusions20 / 48 C25-07_Protocole_ V1.0_01.12.2025 Healthy Volunteers Group
Inclusion: No documented chronic disease
Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosa Maria BRUNO, Professor | Contact | +33 1 53 98 79 67 | rosa-maria.bruno@inserm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INSERM U970, Equipe 7, 56 rue Leblanc | Paris | 75015 | France |
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Participants are assigned in a non-randomized manner to one of five parallel groups according to their pre-existing clinical condition (healthy volunteers, hypertension without CKD, type 2 diabetes without CKD, moderate CKD, severe CKD). All groups undergo the same non-invasive study assessments with the investigational devices (HEMI and SPG-NINOX) during a single study visit, with comparisons performed across groups. Additional predefined subgroups may undergo supplementary assessments (e.g., post-ischemic hyperemia or reproducibility testing).
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| Experimental |
Adults with severe chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit. |
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| SPG-NINOX device | Device | Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel flow and volume-related measures. Measurements are performed during a single study visit under standardized conditions. |
|
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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