Melanoma (Skin Cancer)NCT07740642
A Comparative Usability Study of Two Total Body Skin Imaging Systems
A study testing Deviskan, Vectra WB360 and Standard-of-care clinical examinations in people with Melanoma (Skin Cancer), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin Cancer)
- What is being tested?
- Deviskan, Vectra WB360 and Standard-of-care clinical examinations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Aug 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- ≥ 100 common naevi
- ≥ 5 dysplastic naevi
- dysplastic naevus syndrome
- Known CDKN2A mutation
- Strong family history for melanoma (≥ first- and/or second-degree relatives)
Who cannot join
- 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
Show all 9Show fewer
- Pregnant women (self reported, no pregnancy test planned)
- Height below 150 cm or above 195 cm
- Severe Claustrophobia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4055
Lea Habermacher, +41 61 328 60 48, lea.habermacher@usb.ch
Alexander Navarini, Prof. Dr. med. Dr. sc. nat., +41 61 265 40 84, alexander.navarini@usb.ch
About this study
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)
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.
Read the detailed description
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.
- Conditions
- Melanoma (Skin Cancer)
- Being tested
- Deviskan, Vectra WB360, Standard-of-care clinical examinations
- Keywords
- Screening, Body Photography, Total Body Photography, Dermoscopic Imaging Device, dermoscopy, Body skin imaging, Dysplastic Naevi, CDKN2A Mutation
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeviskanDevice
Autonomous total body photography and dermoscopic imaging system Deviskan, Softwares: Devisoft, Devisual, Deviplatform, (Dermavision Solutions S. L., Figueres, Catalonia, Spain)
Vectra WB360Device
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 examinationsOther
Active control with standard-of-care clinical examinations by experienced dermatologists.
| Study group | Role | What they receive |
|---|---|---|
| Deviskan | Experimental | 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. Receives: Device: Deviskan; Device: Vectra WB360; Other: Standard-of-care clinical examinations |
| Vectra | Experimental | 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. Receives: Device: Deviskan; Device: Vectra WB360; Other: Standard-of-care clinical examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the only study visit, immediately after examination by dermatologist and both medical devices is finished
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the only study visit, immediately after examinations and reevaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start3 Aug 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- A prospective, single center, comparative, observational study with paired design.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740642
- Sponsor's protocol ID
- 2026-D0060; th26navarini
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07740642
- Acronym / sponsor ID
- 2026-D0060; th26navarini
- Conditions
- Melanoma (Skin Cancer)
- Keywords
- Screening, Body Photography, Total Body Photography, Dermoscopic Imaging Device, dermoscopy, Body skin imaging, Dysplastic Naevi, CDKN2A Mutation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, single center, comparative, observational study with paired design.
| Arm | Type | Receives |
|---|---|---|
| Deviskan | Experimental | Device: Deviskan, Device: Vectra WB360, Other: Standard-of-care clinical examinationsGroup 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. |
| Vectra | Experimental | Device: Deviskan, Device: Vectra WB360, Other: Standard-of-care clinical examinationsGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years
- Signed informed consent by the participant
- Sufficient proficiency in German
- At least one of the following risk criteria for melanoma:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeviskanAutonomous total body photography and dermoscopic imaging system Deviskan, Softwares: Devisoft, Devisual, Deviplatform, (Dermavision Solutions S. L., Figueres, Catalonia, Spain) | Device | Deviskan, Vectra |
| Vectra WB3603D total body photography imaging system Vectra WB360, digital dermoscopic camera VISIOMED D200evo dermatoscope, DermaGraphix IntelliStudio, (Canfield Scientific Inc., Parsippany, New Jersey, USA) | Device | Deviskan, Vectra |
| Standard-of-care clinical examinationsActive control with standard-of-care clinical examinations by experienced dermatologists. | Other | Deviskan, Vectra |
Primary outcome
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.
4 secondary outcomes
Patient Questionnaire after examination
Time frame: During the only study visit, immediately after examination by dermatologist and both medical devices is finished
Patient Questionnaire before examination
Time frame: During the only study visit, immediately before examination by dermatologist and both medical devices is started
Patient Questionnaire after examination
Time frame: During the only study visit, immediately after examination by dermatologist and both medical devices is finished
Dermatologists Questionnaire
Time frame: During the only study visit, immediately after examinations and reevaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deviskan, Vectra WB360 and Standard-of-care clinical examinations in people with Melanoma (Skin Cancer), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lea Habermacher (+41 61 328 60 48, lea.habermacher@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Questionnaire after examination (time frame: During the only study visit, immediately after examination by dermatologist and both medical devices is finished). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.