Skin CancerNCT04047316
Development and Validation of a New Digital Dermatoscope in the United States
An observational study of Skin Cancer, run by Barco NV at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Digital dermoscopy
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Aug 2019to 15 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be considered for enrollment in the study when they have a lesion that is accessible to the new digital dermatoscope and are able to give informed consent (guardian in case of patients under 18 years).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dermatologic Surgery Center of Washington LLC
Chevy Chase, Maryland, 20815
Silver Falls Dermatology
Salem, Oregon, 97302
About this study
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.
- Conditions
- Skin Cancer
- Being tested
- Digital dermoscopy
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital dermoscopyDevice
Acquire skin images with a new digital dermatoscope
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the new device in its normal conditions of use
The outcome will be measured by a questionnaire with performance-related questions for clinicians to answer about a set of images from the collected database. A Likert-based scale will be used for the answers: from highly agree to highly disagree.
Measured: 6 months
Usability of the new device
The outcome will be measured by a questionnaire with usability-related questions for clinicians.
Measured: 1 month
Safety of the new device in its normal conditions of use
The number of adverse events will be reported to assess safety of the device.
Measured: 1 year
Secondary outcomes (1)
Develop a database of skin images with the new device with metadata and histopathology of excised lesions
The outcome of the secondary objective will be an anonymized database of digital skin lesion images and corresponding metadata and a set of high quality images amenable to clinician evaluation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start27 Aug 2019
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barco NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047316
- Sponsor's protocol ID
- CI-PROT-0029
- Status last verified
- Jun 2020
- First submitted
- 2 Aug 2019
- Last updated
- 18 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a New Digital Dermatoscope in the United States
- ClinicalTrials.gov ID
- NCT04047316
- Acronym / sponsor ID
- CI-PROT-0029
- Conditions
- Skin Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Barco NVIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be considered for enrollment in the study when they have a lesion that is accessible to the new digital dermatoscope and are able to give informed consent (guardian in case of patients under 18 years).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital dermoscopyAcquire skin images with a new digital dermatoscope | Device | – |
Primary outcome
Performance of the new device in its normal conditions of use
Time frame: 6 months
The outcome will be measured by a questionnaire with performance-related questions for clinicians to answer about a set of images from the collected database. A Likert-based scale will be used for the answers: from highly agree to highly disagree.
Usability of the new device
Time frame: 1 month
The outcome will be measured by a questionnaire with usability-related questions for clinicians.
Safety of the new device in its normal conditions of use
Time frame: 1 year
The number of adverse events will be reported to assess safety of the device.
1 secondary outcome
Develop a database of skin images with the new device with metadata and histopathology of excised lesions
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer, run by Barco NV at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the new device in its normal conditions of use (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020; AzTrials last refreshed its copy on 6 Nov 2026.