NCT07886203 Evaluation of a Point-of-Care, AI-Powered Spectroscopy Device for Triage of Suspicious Vulvar Lesions: A Pilot Study
| NCT ID | NCT07886203 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Vulvar Intraepithelial Neoplasia, HPV-Independent |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-10-06 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2026-10-06 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This purpose of this study is to assess the feasibility of using the DermaSensor™ device on vulvar skin.
Eligibility Criteria
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
Contact & Investigator
Kelly H. Bruce, MD, MS
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT07886203 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Vulvar Intraepithelial Neoplasia, HPV-Independent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07886203 currently recruiting?
Yes, NCT07886203 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT07886203 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07886203 clinical trial?
NCT07886203 is sponsored by Mayo Clinic. The principal investigator is Kelly H. Bruce, MD, MS at Mayo Clinic in Rochester. The trial plans to enroll 20 participants.