An observational study in Skin Cancer and Dermatology/Skin - Other, sponsored by Barco NV. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-29.
Sponsored by Barco NV · Observational
This feasibility study aims to evaluate the use of the BARCO NV digital dermatoscope (non-CE marked device) in the skin cancer clinic. All eligible patients attending the Dermatology outpatient skin cancer clinic will be invited to participate. Patients who consent to the study will undergo standard care which will include medical photography of skin lesion(s) and appropriate management as determined by the Consultant Dermatologist in clinic. In addition to standard care, patients will undergo photography of the same lesion(s) using the BARCO NV digital dermatoscope. There will be no other intervention and no additional hospital visits in relation to the study. Use of the device will not influence the clinical management of the patient.
A detailed experience questionnaire will be administered to all clinicians using the BARCO device to explore their opinion on its ease of use and features.
All standard macroscopic \& dermoscopic images will be taken by OUH medical illustration department and stored on the 'Fotoweb' database (in keeping with current standard practice). Trained Dermatology Consultants, Dermatology Registrars, Research nurses or Medical Photographers, will take BARCO NV device images. A database of all BARCO images will be collected and stored on a dedicated NHS computer separate from the patient clinical record. Standard medical photography images will be stored on Fotoweb as per standard NHS clinical care.
Data will be anonymised and collated and then sent securely to BARCO for further analyses to enable optimization of the BARCO device and for development of diagnostic algorithms in the future.
All eligible \& consenting participants will be approached in a Skin Cancer clinic. Once the clinic consultation has been completed and a decision regarding their management has been made, patients will be invited to consent to the study.
Exclusion Criteria:
Images taken by Clinician in consultation OR in Dermatology department theatres OR images taken in medical photography suite - in the latter case, images can be taken by medical photographer or Research nurse or Dermatologist
Images taken by medical photographer as part of standard care in the medical photography suite.
This is part of standard care and will be undertaken by the clinician who is responsible for the patient
Clinician experience questionnaire results
To assess the acceptability of the new dermoscope in the skin cancer clinic, questions about the usability of the device and about the image quality of the obtained dermoscopic pictures are included.
Time frame: 1 year
Collection of image database
Anonymised database of clinicopathological and digital images of benign, malignant and equivocal skin lesions + Proportion of high quality images amenable to clinician evaluation
Time frame: 1 year
Safety of the device for the patient and the user: occurrence of adverse events
Number of adverse events reported
Time frame: 1 year
This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.