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OpenTrials
Completed

NCT Number: NCT05619471

VIO Imaging for Skin Tissue Assessment (VISTA)

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.

Completed

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Key information

Conditions

Skin Condition Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Neoplasms Neoplasms by Site Skin Abnormalities Skin Cancer Skin Diseases Skin Lesion Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Golden State Dermatology, Merced, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject is between 18 and 99 years of age.
  • The subject or Legally Authorized Representative (LAR) is able and willing to provide written informed consent.
  • The subject is planning to undergo a routine skin biopsy.
  • The subject is willing and able to remain still for periods of up to 3 minutes to allow for image capture.
  • The subject or LAR has sufficient mental capacity to understand the informed consent form (ICF) and comply with the protocol requirements.

Exclusion criteria

  • The subject has a general health condition or systemic disease that in the opinion of the physician, precludes them from trial participation.
  • The subject has a known allergy or increased skin sensitivity to silicone, adhesives, or glycerin.
  • The subject's lesion targeted for biopsy:
  • Is located on the palms of the hands, soles of the feet, fingernails, or toenails.
  • Has dense hair that will not be removed prior to the skin biopsy.
  • Has clinically significant abraded or ulcerated skin with or without discharge.
  • Is associated with a wound or skin condition that in the opinion of the physician precludes them from participation
  • Is located in mucosal tissue (i.e., oral, nasal, etc.).
  • Is on tattooed skin.
  • Is on a skin formation too tortuous for the investigational device to access (e.g., skin tags.)
  • Is located in the periorbital region or directly on the eyelid.

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Treatment and study plan

VIO Imaging

Device

Skin conditions that are candidates for skin biopsies

Primary outcomes

  1. Comparative Reader Percentage Agreement

    Time frame: 8 months post-enrollment completion

    This outcome measured the % agreement and validation of specific tissue features on VIO images in comparison to gold standard pathology images between N=3 Comparative Readers (CRs). "CRs" were study investigators that were selected based on their experience and medical qualifications. 100% agreement and validation between the CRs was required to proceed to the next study phase.

  2. Blinded Reader Percentage Agreement

    Time frame: 8 months post-enrollment completion

    This outcome measured the % agreement between N=3 Blinded Readers (BRs) of their assessment of VIO images in comparison to the answer key developed from the Comparative Reader validation. "BRs" were study investigators that were selected based on their experience and medical qualifications. >90% agreement was required to proceed to the next study phase.

  3. Safety / Adverse Events

    Time frame: 7 +/- 3 days after VIO imaging

    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 outcomes

  1. Inter-Reader Percentage Agreement

    Time frame: 8 months post-enrollment completion

    This outcome measured the inter-reader % agreement between N=3 Blinded Readers (BRs) during image analysis. Minimum 90% agreement was required to proceed to the next study phase.

  2. Evaluation of Secondary Histopathology Characteristics

    Time frame: 8 months post-enrollment completion

    This outcome measured the % agreement between N=3 Blinded Readers (BRs) of their assessment of secondary histopathology characteristics in VIO images in comparison to the answer key developed from the Comparative Reader validation. >90% agreement was required to proceed to the next study phase.

Sponsors and collaborators

Lead sponsor

Enspectra Health

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: VISTA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 17, 2022
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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