VIO Imaging for Skin Tissue Assessment (VISTA)

Enspectra Health

Status: Completed

Conditions: Skin Condition; Skin Cancer; Skin Diseases; Skin Abnormalities; Skin Lesion

Treatments: Device: VIO Imaging

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT05619471

2R44CA221591-03 (U.S. NIH Grant/Contract)

CR-30096

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

65 participants in 1 patient group

VIO Imaging

Experimental group

Description:

Subjects with skin conditions that are candidates for biopsy

Treatment:

Device: VIO Imaging