Inclusion Criteria:

• Age ≥18

• Biopsy proven diagnosis of vulvar SCC, HPV-associated VIN 3, or HPV-independent differentiated VIN planning surgical excision at Mayo 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, CUSA, cryotherapy, or other ablative techniques at the site of device application

• Previous treatment with vulvar radiation therapy at the site of device application

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 06/10/2026. Questions regarding updates should be directed to the study team contact.