SkinScan3D
DeviceA handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI).
Other names: SS3D
NCT Number: NCT06898203
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Kenya Medical Research Institute, Kisumu, Kenya
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Aim 2 (Patients):
Exclusion criteria
- Aim 2 (Patients):
Inclusion criteria
- Aim 3 (Patients):
Exclusion criteria
- Aim 3 (Patients):
A handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI).
Other names: SS3D
Time frame: Approximately 3 months
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 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: 6 months
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 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
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
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.
Contact information is provided by the study sponsor or research team.
Washington University School of Medicine
Other
Precision Imaging to Evaluation Kaposi Sarcoma (PRIME-KS)
Acronym: PRIME-KS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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