A Comparative Usability Study of Two Total Body Skin Imaging Systems

Официальное название

A Comparative Usability Study of Two Total Body Skin Imaging Systems: Vectra (3D Total Body Photography With Manual Dermoscopy) Versus Deviskan (Total Body Photography With Automated Non-Contact Dermoscopy)

Обзор

This study aims to generate evidence on patient and dermatologist perspectives regarding two total body photography systems. Patient and clinician preferences represent key factors in healthcare decision-making. The investigation will also provide data on the time efficiency of each system in a real-world setting.

Подробное описание

Novel tools utilizing artificial intelligence (AI) as total body photography (TBP) and sequential digital dermoscopy imaging (SDDI) with deep-learning algorithms are new approaches with the potential to improve the screening of melanocytic skin lesions by detecting new pigmented lesions as well as dynamic changes in existing moles. TBP with automated non-contact dermoscopy holds the potential to perform these tasks more time efficiently. Both TBP systems enable imaging of the majority of a patient's skin surface. These two systems are distinguished by their methods: the Vectra system requires manual and selective SDDI acquisition using a handheld camera, whereas the Deviskan system automatically captures SDDI for all pigmented lesions exceeding 4 mm, without direct skin contact. Patients receive audio and visual instructions through monitors to maintain specific postures as the camera moves to capture images.

The investigators aim to compare the usability and limits of both devices in a real-world scenario, focusing on the patients' and doctors' preference and opinion. This is the first head-to-head comparison of these two total body photography and dermoscopic imaging devices.

Вмешательства

• Устройство Deviskan
  Autonomous total body photography and dermoscopic imaging system Deviskan, Softwares: Devisoft, Devisual, Deviplatform, (Dermavision Solutions S. L., Figueres, Catalonia, Spain)
• Устройство Vectra WB360
  3D total body photography imaging system Vectra WB360, digital dermoscopic camera VISIOMED D200evo dermatoscope, DermaGraphix IntelliStudio, (Canfield Scientific Inc., Parsippany, New Jersey, USA)
• Другое Standard-of-care clinical examinations
  Active control with standard-of-care clinical examinations by experienced dermatologists.

Первичные конечные точки

• Patient Questionnaire after examination [Срок оценки: During the only study visit, immediately after examination by dermatologist and both medical devices is finished]

Вторичные конечные точки (4)

• Patient Questionnaire after examination [Срок оценки: During the only study visit, immediately after examination by dermatologist and both medical devices is finished]
• Patient Questionnaire before examination [Срок оценки: During the only study visit, immediately before examination by dermatologist and both medical devices is started]
• Patient Questionnaire after examination [Срок оценки: During the only study visit, immediately after examination by dermatologist and both medical devices is finished]
• Dermatologists Questionnaire [Срок оценки: During the only study visit, immediately after examinations and reevaluation]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Signed informed consent by the participant
• Sufficient proficiency in German
• At least one of the following risk criteria for melanoma:

• Previous melanoma (including in situ)
• Suspected melanoma
• ≥ 100 common naevi
• ≥ 5 dysplastic naevi
• dysplastic naevus syndrome
• Known CDKN2A mutation
• Strong family history for melanoma (≥ first- and/or second-degree relatives)

Критерии исключения

• Lack of informed consent
• Immobility. (Patients must be able to stand without support for 30 minutes.)
• Inability to follow the procedures of the investigation, including inability to follow on-screen instructions or to read (e.g. due to visual impairment or cognitive impairment)
• Vulnerable Subjects
• Active skin conditions that may impact the performance of TBP systems or skin cancer screenings
• Cardiac pacemaker
• Pregnant women (self reported, no pregnancy test planned)
• Height below 150 cm or above 195 cm
• Severe Claustrophobia

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Швейцария · 1 центр

• University Hospital Basel — Basel

Идентификаторы

NCT: NCT07740642 · 2026-D0060; th26navarini

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗