Back to resultsVIO Imaging for Skin Tissue Assessment (VISTA) (VISTA)
Primary Purpose
Skin Condition, Skin Diseases, Skin Lesion
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VIO
Sponsored by
About this trial
This is an interventional other trial for Skin Condition
Eligibility Criteria
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. -
Sites / Locations
- Golden State Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with Skin conditions that are candidates for biopsy
Arm Description
Outcomes
Primary Outcome Measures
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.
Safety and Effectiveness
2. >90% agreement between Blinded Reader VIO image assessment and answer key developed from validation assessment.
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.
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT05619471
First Posted
October 26, 2022
Last Updated
September 11, 2023
Sponsor
Enspectra Health
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT05619471
Brief Title
VIO Imaging for Skin Tissue Assessment (VISTA)
Acronym
VISTA
Official Title
VIO Imaging for Skin Tissue Assessment (VISTA) - a Prospective, Multicenter Investigation of the VIO Device in Subjects Undergoing Routine Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
December 29, 2022 (Actual)
Study Completion Date
September 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enspectra Health
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Condition, Skin Diseases, Skin Lesion, Skin Abnormalities
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with Skin conditions that are candidates for biopsy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
VIO
Intervention Description
Skin conditions that are candidates for skin biopsies
Primary Outcome Measure Information:
Title
Safety and Effectiveness
Description
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.
Time Frame
3-months post-Enrollment completion
Title
Safety and Effectiveness
Description
2. >90% agreement between Blinded Reader VIO image assessment and answer key developed from validation assessment.
Time Frame
3-months post-Enrollment completion
Title
Safety and Effectiveness
Description
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.
Time Frame
7day +/- 3 days
Secondary Outcome Measure Information:
Title
1) 90% inter-reader agreement during image analysis phase of the study on the images captured using the investigational device
Description
1) 90% inter-reader agreement during image analysis
Time Frame
3 months post enrollment completion
Title
2) Evaluation of secondary histopathology characteristics using a questionnaire to identify skin features on the images captures on investigational device VIO
Description
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
Time Frame
3 months post enrollment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
-
Facility Information:
Facility Name
Golden State Dermatology
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
VIO Imaging for Skin Tissue Assessment (VISTA)
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