VIO Imaging for Skin Tissue Assessment (VISTA)

• Sponsor: Enspectra Health (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05619471
• Collaborator: National Cancer Institute (NCI) (NIH), National Institutes of Health (NIH) (NIH)
• Enrollment: 65
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5.4
• Patients Per Site Per Month: 12.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Skin Condition; Skin Diseases; Skin Lesion; Skin Abnormalities	Device: VIO	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: VIO Imaging for Skin Tissue Assessment (VISTA) - a Prospective, Multicenter Investigation of the VIO Device in Subjects Undergoing Routine Biopsy
• Actual Study Start Date: Oct 20, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects with Skin conditions that are candidates for biopsy	Device: VIO; Skin conditions that are candidates for skin biopsies

Outcome Measures

Primary Outcome Measures

1. Safety and Effectiveness [3-months post-Enrollment completion]

   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.

2. Safety and Effectiveness [3-months post-Enrollment completion]

   2. >90% agreement between Blinded Reader VIO image assessment and answer key developed from validation assessment.

3. Safety and Effectiveness [7day +/- 3 days]

   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.

Secondary Outcome Measures

1. 1) 90% inter-reader agreement during image analysis phase of the study on the images captured using the investigational device [3 months post enrollment completion]

   1) 90% inter-reader agreement during image analysis

2. 2) Evaluation of secondary histopathology characteristics using a questionnaire to identify skin features on the images captures on investigational device VIO [3 months post enrollment completion]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

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

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

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

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

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

9. Is on tattooed skin.

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

11. Is located in the periorbital region or directly on the eyelid.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Golden State Dermatology	Walnut Creek	California	United States	94598

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Enspectra Health
• ClinicalTrials.gov Identifier: NCT05619471
• Other Study ID Numbers: CR-30096; 2R44CA221591-03
• First Posted: Nov 17, 2022
• Last Update Posted: Nov 17, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Skin Abnormalities; Skin Diseases

Study Results

No Results Posted as of Nov 17, 2022