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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patient Questionnaire after examination
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
To minimise or avoid bias, a study design with a temporary blinding procedure was selected. The investigators are temporary blinded. Firstly, the dermatologists will perform the clinical skin assessment and submit their risk assessment for the patients' pigmented skin lesions (malignant vs. benign). The investigation staff or doctoral candidate will then perform the assessments with the imaging systems. In a final step, the dermatologists will re-evaluate the same pigmented skin lesions with access to all total body photography and dermoscopic images. Investigation subjects and the investigation staff performing the imaging assessments are not blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Deviskan
Group Deviskan will be examined by Deviskan first followed by Vectra. Group Deviskan will receive questionnaire Version A, meaning questions referring to Deviskan are presented before those referring to Vectra.
干预措施: Deviskan (Device)
Deviskan
Group Deviskan will be examined by Deviskan first followed by Vectra. Group Deviskan will receive questionnaire Version A, meaning questions referring to Deviskan are presented before those referring to Vectra.
干预措施: Vectra WB360 (Device)
Deviskan
Group Deviskan will be examined by Deviskan first followed by Vectra. Group Deviskan will receive questionnaire Version A, meaning questions referring to Deviskan are presented before those referring to Vectra.
干预措施: Standard-of-care clinical examinations (Other)
Vectra
Group Vectra will be examined by Vectra first followed by Deviskan. Group Vectra will receive questionnaire Version B, meaning questions referring to Vectra are presented before those referring to Deviskan.
干预措施: Deviskan (Device)
Vectra
Group Vectra will be examined by Vectra first followed by Deviskan. Group Vectra will receive questionnaire Version B, meaning questions referring to Vectra are presented before those referring to Deviskan.
干预措施: Vectra WB360 (Device)
Vectra
Group Vectra will be examined by Vectra first followed by Deviskan. Group Vectra will receive questionnaire Version B, meaning questions referring to Vectra are presented before those referring to Deviskan.
干预措施: Standard-of-care clinical examinations (Other)
结局指标
主要结局
Patient Questionnaire after examination
时间窗: During the only study visit, immediately after examination by dermatologist and both medical devices is finished
Patients rate their perceived safety of examination with Deviskan and Vectra WB360 on a separate unnumbered visual analogue scale for each device. The scale ranges from 0 to 10, 10 indicating the highest possible perceived safety.
次要结局
- Patient Questionnaire after examination(During the only study visit, immediately after examination by dermatologist and both medical devices is finished)
- Patient Questionnaire before examination(During the only study visit, immediately before examination by dermatologist and both medical devices is started)
- Dermatologists Questionnaire(During the only study visit, immediately after examinations and reevaluation)