An observational study in Vulvar Intraepithelial Neoplasia, HPV-Independent, Vulvar Squamous Cell Carcinoma and Vulvar Squamous Intraepithelial Lesion, HPV-Associated, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Mayo Clinic · Observational
This purpose of this study is to assess the feasibility of using the DermaSensor™ device on vulvar skin.
Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.
Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with vulvar squamous cell carcinoma and intraepithelial or invasive neoplasms
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Non-Interventional Study
Non-interventional study
Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study
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.
Time frame: Baseline (at the time of planned surgery)
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.
Time frame: Baseline (at the time of planned surgery)
Descriptive analyses of risk of malignancy
Device output provides a digital display of a binary outcome: "monitor" vs "investigate further," with those lesions classified as "investigate further" being additionally stratified on a scale of 1 to 10 for their spectral similarity to malignant lesions. Risk of malignancy will be reported based on the 1 to 10 result for lesions marked as "investigate further" (1-2, 3-4, 5-6, 7-8, 9-10).
Time frame: Baseline (at the time of planned surgery)
Started Oct 2026 (actual). Primary completion is estimated for Sep 2027, 11 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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