A Comparative Usability Study of Two Total Body Skin Imaging Systems

ConditionMelanoma (Skin Cancer)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity Hospital, Basel, Switzerland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Signed informed consent by the participant

Sufficient proficiency in German

Previous melanoma (including in situ)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: DeviskanExperimental treatment 3 interventions

Group B: VectraExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

Patient Questionnaire after examination

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.

Time frame

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

Patient Questionnaire before examination

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.

Time frame

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

Patient Questionnaire after examination

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.

Time frame

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

Dermatologists Questionnaire

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.

Time frame

During the only study visit, immediately after examinations and reevaluation

Other outcomes

Time efficiency

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

Time frame

During the only study visit, during examinations with medical devices

Time efficiency

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

Time frame

During the only study visit, during examinations with medical devices

Time efficiency

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

Time frame

During the only study visit, during examinations with medical devices

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: