Non-Linear Imaging of Skin In Vivo

Skin Cancer Clinical Trial

— VISION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05410964
• Other study ID #: CR-30062
• Secondary ID: 2R44CA221591-03
• Status: Completed
• Start date: March 28, 2018
• Est. completion date: August 6, 2022

Study information

• Verified date: January 2024
• Source: Enspectra Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 6, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 90 Years

Eligibility

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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Related Conditions & MeSH terms

• Skin Abnormalities
• Skin Cancer
• Skin Condition
• Skin Diseases
• Skin Lesion

Intervention

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

Locations

Country	Name	City	State
United States	Enspectra Health	Mountain View	California

Sponsors (3)

Lead Sponsor	Collaborator
Enspectra Health	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & 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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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