Skin ConditionVISTANCT05619471
VIO Imaging for Skin Tissue Assessment (VISTA)
A study testing VIO Imaging in people with Skin Condition and Skin Diseases, run by Enspectra Health at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Skin Condition, Skin Diseases, Skin Lesion
- What is being tested?
- VIO Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Oct 2022to 11 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Golden State Dermatology
Merced, California, 95340
Golden State Dermatology
Walnut Creek, California, 94598
About this study
Official title: VIO Imaging for Skin Tissue Assessment (VISTA) - a Prospective, Multicenter Investigation of the VIO Device in Subjects Undergoing Routine Biopsy
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.
- Conditions
- Skin Condition, Skin Diseases, Skin Lesion, Skin Abnormalities, Skin Cancer
- Being tested
- VIO Imaging
- Medical subject headings
- Skin Diseases, Skin Abnormalities, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIO ImagingDevice
Skin conditions that are candidates for skin biopsies
| Study group | Role | What they receive |
|---|---|---|
| VIO Imaging | Experimental | Subjects with skin conditions that are candidates for biopsy Receives: Device: VIO Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative Reader Percentage Agreement
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.
Measured: 8 months post-enrollment completion
Blinded Reader Percentage Agreement
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.
Measured: 8 months post-enrollment completion
Safety / Adverse Events
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.
Measured: 7 +/- 3 days after VIO imaging
Secondary outcomes (2)
Inter-Reader Percentage Agreement
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.
Measured: 8 months post-enrollment completion
Evaluation of Secondary Histopathology Characteristics
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.
Measured: 8 months post-enrollment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start20 Oct 2022
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enspectra Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Michael Wang, MD, FAAD, Principal investigator, Golden State Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619471
- Sponsor's protocol ID
- CR-30096
- Other IDs
- 2R44CA221591-03
- Acronym
- VISTA
- Status last verified
- Jul 2024
- First submitted
- 26 Oct 2022
- Last updated
- 25 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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/
PubMed 29461771
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIO Imaging for Skin Tissue Assessment (VISTA) - a Prospective, Multicenter Investigation of the VIO Device in Subjects Undergoing Routine Biopsy
- ClinicalTrials.gov ID
- NCT05619471
- Acronym / sponsor ID
- VISTA / CR-30096
- Conditions
- Skin Condition, Skin Diseases, Skin Lesion, Skin Abnormalities, Skin Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Enspectra HealthIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Posted 25 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIO Imaging | Experimental | Device: VIO ImagingSubjects with skin conditions that are candidates for biopsy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIO ImagingSkin conditions that are candidates for skin biopsies | Device | VIO Imaging |
Primary outcome
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.
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.
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.
2 secondary outcomes
Inter-Reader Percentage Agreement
Time frame: 8 months post-enrollment completion
Evaluation of Secondary Histopathology Characteristics
Time frame: 8 months post-enrollment completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29461771Ward 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/
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wang, MD, FAAD principal investigator
Golden State Dermatology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIO Imaging in people with Skin Condition and Skin Diseases, run by Enspectra Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative Reader Percentage Agreement (time frame: 8 months post-enrollment completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05619471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.