Development and Validation of a New Digital Dermatoscope in the United States

NCT ID: NCT04047316

Last Updated: 2020-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-27

Study Completion Date

2020-04-15

Brief Summary

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A completely new type of digital dermatoscope has been developed in order to take a significant step forward in technology for skin cancer imaging. By means of this study a better insight can be gained of the current performance and workflow in clinical dermatoscopy. This knowledge will be used to further improve the developed technology.

Detailed Description

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Conditions

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Skin Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Digital dermoscopy

Acquire skin images with a new digital dermatoscope

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Male or Female, aged less than 18 years, with informed consent of their legally authorized representative.
* Patient presenting with any visible skin lesion for dermatologist review on a body site amenable to optimal photographic imaging.
* Able and willing to comply with all study requirements.
* Patient with a skin lesion that is clinically diagnosed by a dermatologist as benign, malignant or a suspicious skin lesion requiring excisional biopsy for histological diagnosis.

Exclusion Criteria

* Patients aged under 18 years old where the legally authorized representative is unable or unwilling to provide their informed consent.
* Patients unable to provide informed consent.
* Skin lesions in an anatomical site which is not suitable for photography including hair-obscured site, subungual lesion or inaccessible mucosal site.
* Lesion is at a site where previous surgery was undertaken.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Barco NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dermatologic Surgery Center of Washington LLC

Chevy Chase, Maryland, United States

Site Status

Silver Falls Dermatology

Salem, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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CI-PROT-0029

Identifier Type: -

Identifier Source: org_study_id

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