Diseases and Abnormalities at or Before Birth

All Conditions

Skin and Connective Tissue Diseases

Neoplasms

Congenital Abnormalities

Skin Diseases

Skin Abnormalities

Skin Neoplasms

To investigate the potential for the VIO System to display microscopic skin structure in people of different age, sex, race, and skin health

VIO System

The overall objective of this study is to investigate the potential for the VIO System to display microscopic skin structure in people of different age, sex, race, and skin health.

Non-Linear Imaging of Skin In Vivo

Non-Linear Imaging of Skin In Vivo: VIO In Vivo Skin Imaging evaluatiON (VISION)

Quantify imaging performance in various types of skin, which may include estimated in vivo resolution and imaging depth. Various types of skin includes skin of different people as well as skin in different locations on the body, and skin with skin disease, including basal cell carcinoma.

VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device imaging performance (acceptable/not acceptable) was assessed through engineering expert review of VIO images. The engineering expert review determined whether images were of consistent quality.

Qualitatively evaluate image quality and interpretability by physicians trained in dermatopathology as a function of skin type.

VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device image quality (acceptable/not acceptable) was assessed through clinical expert review of VIO images. The clinical expert review determined whether VIO images could be interpreted by physicians trained in dermatopathology.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Enspectra Health

Healthy subjects, volunteers as well subjects with suspected skin condition recruited from dermatology clinics

VIO Imaging

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Fitzpatrick skin type is a demographic measure of skin pigment and sensitivity to sunlight, as self-reported by participants prior to the study procedure. The measure ranges from Type I (least pigment/most sensitive) to Type VI (most pigment/least sensitive). Refer to PubMed ID: 29461771 for the scale used.

Fitzpatrick Skin Type

Healthy

Suspected or known skin diseases

Skin Health

President

VIO System Imaging Performance assessment was conducted on images taken of all participants

VIO System Imaging Performance

VIO System Image Quality assessment was conducted on images taken of all participants

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Non-Linear Imaging of Skin In Vivo	NCT05410964	Skin Cancer Skin Condition Skin Diseases Skin Lesion Skin Abnormalit...	VIO System	2 Years - 90 Years	Enspectra Health
Non-Linear Imaging of Skin In Vivo	NCT05410964	Skin Cancer Skin Condition Skin Diseases Skin Lesion Skin Abnormalit...	VIO System	2 Years - 90 Years	Enspectra Health

Spots Global Cancer Trial Database for vio system

Every month we try and update this database with for vio system cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vio system

Every month we try and update this database with for vio system cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vio system cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.