RecruitingNCT06976073

Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure


Sponsor

HJN Sverige AB/Neko Health

Enrollment

8,000 participants

Start Date

Feb 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria5

  • 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.

Locations(3)

Atrium Health Care Centre

Stockholm, Sweden

Neko Health Centre, Regeringsgatan

Stockholm, Sweden

Neko Health Centre, Sibyllegatan

Stockholm, Sweden

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NCT06976073


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