VIO Imaging for Skin Tissue Assessment (VISTA)

Skin Cancer Clinical Trial

— VISTA  

Official title:

VIO Imaging for Skin Tissue Assessment (VISTA) - a Prospective, Multicenter Investigation of the VIO Device in Subjects Undergoing Routine Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05619471
• Other study ID #: CR-30096
• Secondary ID: 2R44CA221591-03
• Status: Completed
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: August 11, 2023

Study information

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

Clinical Trial Summary

To demonstrate the safety and effectiveness of the VIO device in obtaining in vivo images that show tissue features including epidermis, dermis, collagen, blood vessels, and/or pigment. To demonstrate that the tissue features identified on the images obtained with the VIO device align with the corresponding pathology images procured from the skin biopsy. To evaluate the ability of blinded readers to correctly identify tissue features on images obtained with the VIO device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 11, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. The subject is between 18 and 99 years of age.

2. The subject or Legally Authorized Representative (LAR) is able and willing to provide written informed consent.

3. The subject is planning to undergo a routine skin biopsy.

4. The subject is willing and able to remain still for periods of up to 3 minutes to allow for image capture.

5. The subject or LAR has sufficient mental capacity to understand the informed consent form (ICF) and comply with the protocol requirements.

Exclusion Criteria:

1. The subject has a general health condition or systemic disease that in the opinion of the physician, precludes them from trial participation.

2. The subject has a known allergy or increased skin sensitivity to silicone, adhesives, or glycerin.

3. The subject's lesion targeted for biopsy:

1. Is located on the palms of the hands, soles of the feet, fingernails, or toenails.

2. Has dense hair that will not be removed prior to the skin biopsy.

3. Has clinically significant abraded or ulcerated skin with or without discharge.

4. Is associated with a wound or skin condition that in the opinion of the physician precludes them from participation

5. Is located in mucosal tissue (i.e., oral, nasal, etc.).

6. Is on tattooed skin.

7. Is on a skin formation too tortuous for the investigational device to access (e.g., skin tags.)

8. Is located in the periorbital region or directly on the eyelid. -

Related Conditions & MeSH terms

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

Intervention

Device:
• VIO Imaging
Skin conditions that are candidates for skin biopsies

Locations

Country	Name	City	State
United States	Golden State Dermatology	Merced	California
United States	Golden State Dermatology	Walnut Creek	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	Safety and Effectiveness	1. 100% agreement and validation of specific tissue features on VIO images (epidermis, dermis, collagen, blood vessels and pigment) in comparison to gold standard pathology images in Comparative Reader assessment.	3-months post-Enrollment completion
Primary	Safety and Effectiveness	2. >90% agreement between Blinded Reader VIO image assessment and answer key developed from validation assessment.	3-months post-Enrollment completion
Primary	Safety and Effectiveness	3. Safety will be assessed as the incidence of all adverse events (analyzed by severity, seriousness, and relationship to the device and procedure) that occur through the 7-day follow-up period.	7day +/- 3 days
Secondary	1) 90% inter-reader agreement during image analysis phase of the study on the images captured using the investigational device	1) 90% inter-reader agreement during image analysis	3 months post enrollment completion
Secondary	2) Evaluation of secondary histopathology characteristics using a questionnaire to identify skin features on the images captures on investigational device VIO	Evaluation of secondary histopathology characteristics using a questionnaire to identify skin features on the images captured on the investigational device VIO; including but not limited to; Dermal elastosis; Cellular nodules within dermis will be evaluated during image analysis; Large keratinocytes	3 months post enrollment completion