Utility of Digital Dermoscopy in the Skin Cancer Clinic
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|ClinicalTrials.gov Identifier: NCT03497455|
Recruitment Status : Active, not recruiting
First Posted : April 13, 2018
Last Update Posted : June 10, 2019
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.
|Condition or disease||Intervention/treatment|
|Skin Cancer Dermatology/Skin - Other||Device: Barco NV Digital Dermatoscope device images Device: Standard medical photographs including dermoscopy images Other: Clinic proforma completion|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Feasibility Study to Evaluate Utility of the BARCO NV Digital Dermatoscope in the Skin Cancer Clinic|
|Actual Study Start Date :||July 12, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- Device: Barco NV Digital Dermatoscope device images
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
- Device: Standard medical photographs including dermoscopy images
Images taken by medical photographer as part of standard care in the medical photography suite.
- Other: Clinic proforma completion
This is part of standard care and will be undertaken by the clinician who is responsible for the patient
- Clinician experience questionnaire results [ Time Frame: 1 year ]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.
- Collection of image database [ Time Frame: 1 year ]Anonymised database of clinicopathological and digital images of benign, malignant and equivocal skin lesions + Proportion of high quality images amenable to clinician evaluation
- Safety of the device for the patient and the user: occurrence of adverse events [ Time Frame: 1 year ]Number of adverse events reported
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497455
|Oxford University Hospitals NHS Foundation Trust|
|Oxford, United Kingdom, OX3 7LE|