Non-Linear Imaging of Skin In Vivo (VISION)

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Diseases; Skin Abnormalities; Skin Cancer; Skin Lesion; Skin Condition
• Intervention / Treatment: Device: VIO System

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• United States
  • California
    • Mountain View, California, United States, 94040
      • Enspectra Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Arm	Device: VIO System; To investigate the potential for the VIO System to display microscopic skin structure in people of different age, sex, race, and skin health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VIO System Imaging Performance	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.	3 hours
VIO System Image 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.	3 hours

Collaborators and Investigators

• Sponsor: Enspectra Health
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)

Publications and helpful links

General Publications

• Ward WH, Farma JM, editors. Cutaneous Melanoma: Etiology and Therapy [Internet]. Brisbane (AU): Codon Publications; 2017 Dec 21. Available from http://www.ncbi.nlm.nih.gov/books/NBK481860/

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Actual): July 29, 2022
• Study Completion (Actual): August 6, 2022

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Skin Diseases; Skin Abnormalities
• Other Study ID Numbers: CR-30062; 2R44CA221591-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No