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

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Sweden
Atrium Health Care Centre
RECRUITING
Stockholm
Neko Health Centre, Regeringsgatan
RECRUITING
Stockholm
Neko Health Centre, Sibyllegatan
RECRUITING
Stockholm
Contact Information
Primary
Mattias Windå, MSc
mattias@nekohealth.com
+46703169040
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 8000
Treatments
patient_cohort
Adult patients mainly from a primary care cohort. All patients visiting the clinical sites, seeking care, or as separately invited, are offered to participate in this investigation. This includes sub-groups of patients with conditions such as diabetes mellitus, peripheral arterial disease and skin cancer. All participants undergo at least one examination with the investigational device (TCI P3).
Sponsors
Leads: HJN Sverige AB/Neko Health

This content was sourced from clinicaltrials.gov