Clinical trial · Interventional
VIO Imaging for Skin Tissue Assessment (VISTA)
VIO Imaging for Skin Tissue Assessment (VISTA) - a Prospective, Multicenter Investigation of the VIO Device in Subjects Undergoing Routine Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Abnormalities | — | UNRESOLVED | — |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Skin Condition | — | UNRESOLVED | — |
| Skin Diseases | — | UNRESOLVED | — |
| Skin Lesion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VIO Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VIO Imaging
- description
- Subjects with skin conditions that are candidates for biopsy
- interventionNames
- Device: VIO Imaging
Primary outcomes (3)
- measure
- Comparative Reader Percentage Agreement
- timeFrame
- 8 months post-enrollment completion
- description
- 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.
- measure
- Blinded Reader Percentage Agreement
- timeFrame
- 8 months post-enrollment completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
\-References
Publications (1)
- BACKGROUNDWard 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/ PMID 29461771