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NCT Number: NCT07740642

A Comparative Usability Study of Two Total Body Skin Imaging Systems

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.

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Key information

Conditions

Melanoma (Skin Cancer) Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Deviskan

Device

Autonomous total body photography and dermoscopic imaging system Deviskan, Softwares: Devisoft, Devisual, Deviplatform, (Dermavision Solutions S. L., Figueres, Catalonia, Spain)

Vectra WB360

Device

3D total body photography imaging system Vectra WB360, digital dermoscopic camera VISIOMED D200evo dermatoscope, DermaGraphix IntelliStudio, (Canfield Scientific Inc., Parsippany, New Jersey, USA)

Standard-of-care clinical examinations

Other

Active control with standard-of-care clinical examinations by experienced dermatologists.

Primary outcomes

  1. Patient Questionnaire after examination

    Time frame: 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.

Secondary outcomes

  1. Patient Questionnaire after examination

    Time frame: During the only study visit, immediately after examination by dermatologist and both medical devices is finished

    Reference points: patients rate their perceived safety after clinical examination by dermatologist alone, and after combination of clinical examination and AI-based imaging on separate unnumbered visual analogue scales for the examination by dermatologist and the combinations. The scale ranges from 0 to 10, 10 indicating the highest possible perceived safety.

  2. Patient Questionnaire before examination

    Time frame: During the only study visit, immediately before examination by dermatologist and both medical devices is started

    Topics: Height, bodyweight, age, gender, level of education, reason for examination, previous experience with TBP, perceived diagnostic potential of AI, preference regarding AI involvement in diagnostics, willingness to pay out of pocket, subjective level of worry about developing melanoma and level of tension previously to examination. Assessed using visual analogue scales, predefined multiple-choice items and open comment fields.

  3. Patient Questionnaire after examination

    Time frame: During the only study visit, immediately after examination by dermatologist and both medical devices is finished

    Topics: comfort, privacy, preference, fear of developing skin cancer after different examinations, open comment field. Assessed using visual analogue scales, predefined multiple-choice items and comment field.

  4. Dermatologists Questionnaire

    Time frame: During the only study visit, immediately after examinations and reevaluation

    Questions regarding user-friendliness of medical devices, perceived thoroughness, subjective assessment of image quality, influence of TBP on clinical decision, preferred examination strategy for this patient.

    Assessed using visual analogue scales and predefined multiple-choice items.

Other outcomes

  1. Time efficiency

    Time frame: During the only study visit, during examinations with medical devices

    Total examination time for Deviskan vs. Vectra WB360 will be recorded with stopwatches.

  2. Time efficiency

    Time frame: During the only study visit, during examinations with medical devices

    Mean time per dermoscopic image captured by each device will be calculated.

  3. Time efficiency

    Time frame: During the only study visit, during examinations with medical devices

    Correlation between number of images captured and total examination time will be investigated.

Study contacts

Contact information is provided by the study sponsor or research team.

Lea Habermacher

CONTACT

[email protected]

+41 61 328 60 48

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

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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