Non-Linear Imaging of Skin In Vivo (VISION)

Enspectra Health

Status: Completed

Conditions: Skin Condition; Skin Diseases; Skin Cancer; Skin Abnormalities; Skin Lesion

Treatments: Device: VIO System

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT05410964

CR-30062

2R44CA221591-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 2 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects, ages 2 - 90 years old.
2. Subject, or guardian, if applicable, must be willing to provide written informed consent prior to enrollment and agree to comply with protocol requirements. If applicable, child must be willing to provide written assent prior to enrollment and agree to comply with protocol requirements.
3. Subject or guardian, if applicable, must have sufficient mental capacity to understand the Informed Consent and provide clinically relevant and reliable feedback regarding their experience with the device.
4. Subject and guardian, if applicable, must comply with the protocol requirements.
5. Subject or guardian, if applicable, must agree that anonymized personal data will be made available to Study Sponsor and requisite regional and international regulatory bodies.

Exclusion criteria

1. Any general health condition or systemic disease that may represent, in the opinion of the Principal Investigator, a potential increased risk associated with device use

2. Currently infected with a communicable skin infection (e.g., shingles or methicillin-resistant S. aureus), which does not include local and minimally pathogenic or non-pathogenic infections distant from the imaging location(s) (e.g., warts, acne)

3. Any known allergies to any materials used in the preparation of skin and/or device use

4. Has a temporary or permanent electrical implanted medical device

Trial design

122 participants in 1 patient group

Single Arm

Treatment:

Device: VIO System