Recruiting

DermaSensor™

Sponsor:

Mayo Clinic

Code:

NCT07886203

Conditions

Vulvar Intraepithelial Neoplasia, HPV-Independent

Vulvar Squamous Cell Carcinoma

Vulvar Squamous Intraepithelial Lesion, HPV-Associated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

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

Study ID

NCT07886203

Start date

Oct 6, 2026

Status verified date

Oct, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Device output and clinical gold standard [ Time Frame: Baseline (at the time of planned surgery) ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

OBGYN Research Team

507-422-3902

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

OBGYN Research Team

507-422-3902

Principal Investigator:

Kelly H. Bruce, MD, MS

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.