NCT06976073 Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure
| NCT ID | NCT06976073 |
| Status | Recruiting |
| Phase | — |
| Sponsor | HJN Sverige AB/Neko Health |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | OBSERVATIONAL |
| Enrollment | 8,000 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 8,000 participants in total. It began in 2023-02-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical investigation is to explore a non-invasive technology for measuring the microcirculatory structure, composition and function in patients from a primary care population. The main aims are: 1. To evaluate the robustness of the technology for assessment of the molecular composition and structure of the skin tissue and microcirculatory function, on a prospective primary care population. 2. To evaluate the device and method on its capability to detect deficiencies in circulation, compared with existing reference systems with similar characteristics for patients with known cardiovascular disease risk and/or diabetes.
Eligibility Criteria
Inclusion Criteria: * Adult patients part of the regular healthcare patient flow at the investigational sites, or as separately invited to participate in this investigation. * Patients with signed informed consent Exclusion Criteria: * Cognitive impairment * Patients unable to understand the oral and written study information in Swedish or English * Other severe disorder or terminal disease * Patients unable to provide an informed consent * Patient´s with damaged, scarred or non-intact skin within the skin area of interest.
Contact & Investigator
Samuel Rodgers, MD
PRINCIPAL INVESTIGATOR
HJN Sverige AB/Neko Health AB
Frequently Asked Questions
Who can join the NCT06976073 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06976073 currently recruiting?
Yes, NCT06976073 is actively recruiting participants. Contact the research team at mattias@nekohealth.com for enrollment information.
Where is the NCT06976073 trial being conducted?
This trial is being conducted at Stockholm, Sweden, Stockholm, Sweden, Stockholm, Sweden.
Who is sponsoring the NCT06976073 clinical trial?
NCT06976073 is sponsored by HJN Sverige AB/Neko Health. The principal investigator is Samuel Rodgers, MD at HJN Sverige AB/Neko Health AB. The trial plans to enroll 8,000 participants.
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