An interventional study of SkinScan3D in Kaposi Sarcoma, sponsored by Washington University School of Medicine. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Other
AIMS 2 \& 3:
In this study the investigators seek to formally compare reproducibility and accuracy of KS lesion size measurements between SkinScan3D and the current standard of care manual measurement method. The investigators will then test the SS3D device on 100 patients in a variety of real-world practice locations to determine whether the device will be usable, acceptable, appropriate, and feasible in routine care settings.
161 studies on the registry are indexed under Sarcoma, Kaposi; 24 are open to participants now.
This study's planned enrollment of 180 is above the median of 30 across 114 interventional studies indexed under Sarcoma, Kaposi.
Browse Sarcoma, Kaposi studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria - Aim 2 (Patients):
Exclusion Criteria - Aim 2 (Patients):
Inclusion Criteria - Aim 3 (Patients):
Exclusion Criteria - Aim 3 (Patients):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will have three discrete skin lesions measured, with lesion area determined by ACTG criteria utilizing the product of longest perpendicular diameters. Patients will also have five 3D snapshots of each of the three target lesions taken, measuring lesion area automatically using SS3D.
Device: SkinScan3D
Providers will first measure KS lesions using the manual ruler-based method as per usual standard of care for the first three months. After the first three months, providers will switch to using SkinScan3D for KS skin lesion measurement.
Device: SkinScan3D
A handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI).
Also known as: SS3D
Reproducibility of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only
Reproducibility/agreement between clinicians for each method is measured using the concordance correlation coefficient (CCC). A higher CCC means a more reproducible method.
Time frame: Approximately 3 months
Accuracy of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only
Accuracy is measured using the coefficient of determination (R-squared). The R-squared tells us how much variation is due to varying lesion size as measured by either method versus how much variation is due to random error. When the variation due to random error is small, the R-squared value is closer to 1; when the variation due to random error is large, the R-squared value is farther from 1.
Time frame: Approximately 3 months
Device usability - Aim 3 Only
Device usability will be measured using the System Usability Scale. The SUS will result in a single composite score for each individual and the scores will be averaged to result in a single overall usability score.
Time frame: 6 months
Acceptability - Aim 3 Only
Acceptability of Intervention Measure (AIM), present participants with a set of 4 questions regarding their perception of an intervention's acceptability, typically on a 5-point Likert scale (completely disagree to completely agree), then calculate the average score across all items, with higher scores indicating greater perceived acceptability of the intervention.
Time frame: 6 months
Appropriateness - Aim 3 Only
Intervention Appropriateness Measure (IAM), will present a set of four questions to healthcare providers about how well SS3D works in their context. Each item is rated on a Likert scale, with higher scores indicating greater perceived appropriateness.
Time frame: 6 months
Feasibility - Aim 3 Only
FIM (Feasibility of Intervention Measure), will give the four-item questionnaire to healthcare providers asking them to rate how feasible they believe a specific intervention is on a Likert scale, usually ranging from "completely disagree" to "completely agree"; a higher score indicates greater perceived feasibility, with the average score across all items representing the overall feasibility rating of the intervention in that context.
Time frame: 6 months
Plan to share: Yes — All participants will consent to the sharing of aggregate de-identified quantitative and qualitative data. Any potentially identifying variables will be stripped from the public-use data in compliance with Washington University IRB policies and human subject protections. Participants will have the option to consent to sharing their identifiable survey data for future research and scholarly use as part of a data donation agreement. These identifiable data will be made available as a separate, identifiable dataset in WURD. All deidentified study data that are not designated as restricted use will be made available as public use data to the research community via the WURD or QDR. Data that are determined to be potentially identifying though indirect or deductive disclosure are provided under restricted data contract to users who have a valid research need and meet conditions of use.
Supporting information: Study protocol, Statistical analysis plan
Time frame: All data associated with study will be made available at the time of the first publication associated with the data. We anticipate that this will occur approximately 12 months following the completion of field work and within the award period. Study data deposited in WURD and QDR will be available to the public in perpetuity. Datasets related to methodological publications will be shared at publication.
Access criteria: Contact Dr. Thomas Odeny
Started Apr 2026 (actual). Primary completion is estimated for Nov 2028, 31 months after the start.
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