Non-Linear Imaging of Skin In Vivo

NCT05410964 | Completed Results FDA Device

• 2 other identifiers: CR-300622R44CA221591-03
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Cancer; Skin Condition; Skin Diseases; Skin Lesion; Skin Abnormalities

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Single Arm

Device: VIO System

Interventions

VIO System DEVICE

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

Single Arm

Eligibility Criteria

• Age: 2 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Subjects, ages 2 - 90 years old.
• 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.
• 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.
• Subject and guardian, if applicable, must comply with the protocol requirements.
• 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.

You may not qualify if:

• 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
• 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)
• Any known allergies to any materials used in the preparation of skin and/or device use
• Has a temporary or permanent electrical implanted medical device

Sponsors & Collaborators

• Enspectra Health: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Enspectra Health

Mountain View, California, 94040, United States

Location

Related Publications (1)

• 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/

  PMID: 29461771 BACKGROUND

MeSH Terms

Conditions

Skin Neoplasms; Skin Diseases; Skin Abnormalities

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin and Connective Tissue Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: President
• Organization: Enspectra Health

clinical@enspectrahealth.com

650 480-6022

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 8, 2022
• Study Start: March 28, 2018
• Primary Completion: July 29, 2022
• Study Completion: August 6, 2022
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Locations

US (1)