Evaluation of a Point-of-Care, AI-Powered Spectroscopy Device for Triage of Suspicious Vulvar Lesions: A Pilot Study

This purpose of this study is to assess the feasibility of using the DermaSensor™ device on vulvar skin.

Inclusion Criteria: * Age ≥ 18 * Biopsy proven diagnosis of vulvar squamous cell carcinoma (SCC), human papillomavirus (HPV)-associated VIN 3, or HPV-independent differentiated vulvar intraepithelial neoplasia (VIN) planning surgical excision at Mayo Clinic in Rochester * Ability to provide informed consent, including with the assistance of an in-person or virtual interpreter * Multiple distinct lesions on the same patient may be included as distinct device applications, up to two non-contiguous lesions Exclusion Criteria: * Pregnancy * Incarceration * Lesion proximal to the hymen (no vaginal or peri-urethral mucosal lesions) * Lesions at the anal verge * Absence of residual lesion beyond prior biopsy or surgical site (device cannot be applied on a healing biopsy site or surgical scar) * Lesion covered with excessive crust, erosion, or ulceration * Previous treatment with CO2 laser, cavitational ultrasonic surgical aspiration (CUSA), cryotherapy, or other ablative techniques at the site of device application * Previous treatment with vulvar radiation therapy at the site of device application