A Comparative Usability Study of Two Total Body Skin Imaging Systems | NCT07740642

NCT07740642

Overview

NCT ID: NCT07740642
Lead Sponsor: University Hospital, Basel, SwitzerlandOTHER
Official 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)
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)
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Aug 3, 2026Estimated
Primary Completion Date: Sep 30, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 60Estimated
Primary Purpose: Screening
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Lea HabermacherContact
lea.habermacher@usb.ch+41 61 328 60 48

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Masking Description

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.

Participant Group/Arms

DeviskanExperimental

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

VectraExperimental

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