Vulvar Intraepithelial Neoplasia, HPV-IndependentNCT07886203
Evaluation of a Point-of-Care, AI-Powered Spectroscopy Device for Triage of Suspicious Vulvar Lesions: A Pilot Study
An observational study of Vulvar Intraepithelial Neoplasia, HPV-Independent and Vulvar Squamous Cell Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This purpose of this study is to assess the feasibility of using the DermaSensor™ device on vulvar skin. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Intraepithelial Neoplasia, HPV-Independent, Vulvar Squamous Cell Carcinoma, Vulvar Squamous Intraepithelial Lesion, HPV-Associated
- What is being tested?
- Non-Interventional Study
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2026to 30 Sep 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with vulvar squamous cell carcinoma and intraepithelial or invasive neoplasms
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
OBGYN Research Team contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
OBGYN Research Team, 507-422-3902
Kelly H. Bruce, MD, MS
About this study
This purpose of this study is to assess the feasibility of using the DermaSensor™ device on vulvar skin.
- Conditions
- Vulvar Intraepithelial Neoplasia, HPV-Independent, Vulvar Squamous Cell Carcinoma, Vulvar Squamous Intraepithelial Lesion, HPV-Associated
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo DermaSensor™ device recordings as well as photography of sites of device use during standard of care surgical excision. Patients also have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device output and clinical gold standard
Will assess diagnostic triage performance of DermaSensor™ on vulvar skin by comparing device reading to clinical gold standard (histopathology for diseased site and clinician expert visual inspection for control site). Descriptive statistics will be utilized to broadly analyze the sample.
Measured: Baseline (at the time of planned surgery)
Secondary outcomes (1)
Feasibility of device application on vulvar skin
Will conduct qualitative interviews to assess surgeon experience with device use, including ease of use and feasibility. Will use thematic analysis to identify potential barriers for device application in this novel setting.
Measured: Baseline (at the time of planned surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start6 Oct 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar Intraepithelial Neoplasia, HPV-IndependentStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly H. Bruce, MD, MS, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886203
- Sponsor's protocol ID
- 26-004371
- Other IDs
- NCI-2026-06704
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated device
- Yes