A Comparative Usability Study of Two Total Body Skin Imaging Systems

NCT07740642 | Not Yet Recruiting

• 1 other identifier: 2026-D0060; th26navarini
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma (Skin Cancer)

Keywords

Screening; Body Photography; Total Body Photography; Dermoscopic Imaging Device; dermoscopy; Body skin imaging; Dysplastic Naevi; CDKN2A Mutation

Outcome Measures

Primary Outcomes (1)

• Patient Questionnaire after examination

  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.

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

Secondary Outcomes (4)

• 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

• Patient Questionnaire after examination

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

• Dermatologists Questionnaire

  During the only study visit, immediately after examinations and reevaluation

Other Outcomes (3)

• Time efficiency

  During the only study visit, during examinations with medical devices

• Time efficiency

  During the only study visit, during examinations with medical devices

• Time efficiency

  During the only study visit, during examinations with medical devices

Study Arms (2)

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.

Device: Deviskan; Device: Vectra WB360; Other: Standard-of-care clinical examinations

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.

Device: Deviskan; Device: Vectra WB360; Other: Standard-of-care clinical examinations

Interventions

Deviskan DEVICE

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

Deviskan; Vectra

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)

Deviskan; Vectra

Standard-of-care clinical examinations OTHER

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

Deviskan; Vectra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the University Hospital Basel with skin cancer screening consultations and outpatient clinic appointments at the Department of Dermatology.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4055, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skin biopsies in case of suspicion of malignant skin growth.

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lea Habermacher

CONTACT

+41 61 328 60 48; lea.habermacher@usb.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)