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New Non-Invasive devices aim to spot hidden blood vessel damage

NCT ID NCT07604922

Knowledge-focused Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study will test two new non-invasive devices (HEMI and SPG-NINOX) that measure small blood vessel function in 165 adults. Participants include healthy volunteers and people with high blood pressure, type 2 diabetes, or chronic kidney disease. The goal is to see if these devices can detect early blood vessel changes linked to these conditions, without any needles or procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could lead to a simple, non-invasive way to detect early blood vessel damage in people with kidney disease, diabetes, or high blood pressure.
What could go wrong
This is an early observational study, not a treatment trial. The devices are still investigational, and results may not lead to a widely available test.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 165 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Common Inclusion Criteria: * Adults aged over 18 years, of both sexes * Patients eligible for or affiliated with a social security scheme * Patients who have provided written informed consent to participate in the study Common Exclusion Criteria: * Inability to give informed consent * Persons under legal protection (guardianship, trusteeship, or court protection) * Language barrier or psychological refusal to read the information * Medical conditions with a life expectancy \< 1 year according to clinical judgment * Ongoing participation restriction due to another clinical research study * Pregnant women (due to physiological hemodynamic changes in blood pressure and arterial stiffness during pregnancy) * Cardiac arrhythmias: current atrial fibrillation or high-degree atrioventricular block Exclusion Criteria: * Hypertension Group * Inclusion: Prior diagnosis of arterial hypertension * Stable cardiovascular treatment in the previous 1 month * Exclusion: * CKD with GFR \<60 mL/min * ACR \> 30 mg/mmol * Type 2 diabetes Type 2 Diabetes Group * Inclusion: * Prior diagnosis of type 2 diabetes * Stable cardiovascular treatment in the previous 1 month * Exclusion: * CKD with GFR \< 60 mL/min * ACR \> 30 mg/mmol Moderate CKD Group * 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: * Severe CKD (GFR \< 30 mL/min for ≥ 2 months) * Patients scheduled for arterial stiffness assessment as part of routine care * Stable cardiovascular treatment the previous 1 month * 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: * Moderate or severe CKD (GFR \< 60 mL/min) (CKD-EPI) * Hypertension * Type 2 diabetes * Stable cardiovascular treatment in the previous 1 month

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome hypertensive disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease Hypertension (HTN) Type 2 diabetes mellitus (T2DM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • INSERM U970, Equipe 7, 56 rue Leblanc

    Paris, 75015, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.