Trial · NCT07886203
Evaluation of a Point-of-Care, AI-Powered Spectroscopy Device for Triage of Suspicious Vulvar Lesions: A Pilot Study
NCT07886203, Recruiting, Mayo Clinic
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of a Point-of-Care, AI-Powered Spectroscopy Device for Triage of Suspicious Vulvar Lesions: A Pilot Study. Trials, record NCT07886203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07886203
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of a Point-of-Care, AI-Powered Spectroscopy Device for Triage of Suspicious Vulvar Lesions: A Pilot Study
- NCT number
- NCT07886203
- Status
- Recruiting
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Mayo Clinic
- Conditions
- Vulvar Intraepithelial Neoplasia, HPV-Independent, Vulvar Squamous Cell Carcinoma, Vulvar Squamous Intraepithelial Lesion, HPV-Associated
- Interventions
- Non-Interventional Study
- First posted
- 2026-10-21
- Last updated
- 2026-10-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Device output and clinical gold standard | Baseline (at the time of planned surgery) | 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. |
| Secondary | Feasibility of device application on vulvar skin | Baseline (at the time of planned surgery) | 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. |
| Other | Descriptive analyses of risk of malignancy | Baseline (at the time of planned surgery) | 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). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07886203
GET https://conductscience.org/api/trials/v1/NCT07886203/registered