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临床试验/NCT03497455
NCT03497455终止不适用

Feasibility Study to Evaluate Utility of the BARCO NV Digital Dermatoscope in the Skin Cancer Clinic

Barco NV1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2018年7月12日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
Barco NV
入组人数
13
试验地点
1
主要终点
Clinician experience questionnaire results

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Patient presenting with any visible skin lesion for Dermatologist review on a body site amenable for optimal photographic imaging
  • Able and willing to comply with all study requirements.
  • Patient with a skin lesion that is clinically diagnosed by a Consultant Dermatologist as benign OR a suspicious skin lesion requiring excisional biopsy for histological diagnosis
  • Patient attending for a 'New' or 'Follow-up' consultation

排除标准

  • Patients aged under 18 years old
  • Patients unable to provide informed consent
  • Skin lesions in an anatomical site which is not suitable for photography including genital lesion, hair-bearing site or subungual lesion
  • Maximum size of lesion 25 mm
  • Lesion is at a site where previous surgery was undertaken
  • Lesion on a mucosal site

结局指标

主要结局

Clinician experience questionnaire results

时间窗: 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.

次要结局

  • Collection of image database(1 year)
  • Safety of the device for the patient and the user: occurrence of adverse events(1 year)

研究者

发起方
Barco NV
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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