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NCT07740642
A Comparative Usability Study of Two Total Body Skin Imaging Systems
Conditions: Melanoma (Skin Cancer)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: University Hospital, Basel, Switzerland
Location: University Hospital Basel Basel Canton of Basel-City
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.
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
Source: ClinicalTrials.gov (NCT07740642). StuddyBuddy aggregates publicly available trial information.