Skin Cancer Clinical Trial
— VISTAOfficial title:
VIO Imaging for Skin Tissue Assessment (VISTA) - a Prospective, Multicenter Investigation of the VIO Device in Subjects Undergoing Routine Biopsy
Verified date | April 2024 |
Source | Enspectra Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | August 11, 2023 |
Est. primary completion date | August 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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. - |
Country | Name | City | State |
---|---|---|---|
United States | Golden State Dermatology | Merced | California |
United States | Golden State Dermatology | Walnut Creek | California |
Lead Sponsor | Collaborator |
---|---|
Enspectra Health | National Cancer Institute (NCI), National Institutes of Health (NIH) |
United States,
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/ — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3-months post-Enrollment completion | |
Primary | Safety and Effectiveness | 2. >90% agreement between Blinded Reader VIO image assessment and answer key developed from validation assessment. | 3-months post-Enrollment completion | |
Primary | 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. | 7day +/- 3 days | |
Secondary | 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 | 3 months post enrollment completion | |
Secondary | 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 |
3 months post enrollment completion |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02721459 -
XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma
|
Phase 1 | |
Completed |
NCT03740815 -
Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection
|
N/A | |
Recruiting |
NCT05779423 -
Cryoablation+Ipilimumab+Nivolumab in Melanoma
|
Phase 2 | |
Terminated |
NCT01468818 -
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT01820234 -
Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event
|
N/A | |
Completed |
NCT00535769 -
Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use
|
Phase 0 | |
Completed |
NCT00526032 -
Melanoma Detection by Oblique-Incidence Optical Spectroscopy
|
N/A | |
Completed |
NCT00588341 -
Phase II Trial of Neoadjuvant Temozolomide in Melanoma Patients With Palpable Stage III or IV Disease Undergoing Complete Surgical Resection
|
Phase 2 | |
Active, not recruiting |
NCT01447199 -
The Molecular Predisposition to Hereditary Nonpolyposis Colon Cancer (HNPCC)
|
||
Enrolling by invitation |
NCT04758988 -
AI Augmented Training for Skin Specialists
|
N/A | |
Not yet recruiting |
NCT04534868 -
Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area
|
N/A | |
Recruiting |
NCT04138342 -
Topical Fluorescent Nanoparticles Conjugated Somatostatin Analog for Suppression and Bioimaging Breast Cancer
|
Phase 1 | |
Completed |
NCT03673917 -
Cosmetology Students and Skin Cancer
|
N/A | |
Recruiting |
NCT04341064 -
Sun-safe Habits Intervention and Education
|
Phase 3 | |
Completed |
NCT04206995 -
Cancer Sensing: Evaluation of Odour Sampling Techniques
|
||
Recruiting |
NCT05574101 -
A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer
|
Phase 2 | |
Not yet recruiting |
NCT05860881 -
Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)
|
Phase 3 | |
Completed |
NCT05146622 -
Virtual Sun Safe Workplaces Ph I
|
||
Recruiting |
NCT05068310 -
Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors
|
||
Recruiting |
NCT03889899 -
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.
|
N/A |