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