CompletedNot Applicable

Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions

Spain65 participantsStarted 2022-11-28

Plain-language summary

The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods: * Ruler using the Kundin method, * Investigational software Clinicgram Euclides * Digital planimetry with Adobe Photoshop The clinical data retrieved in this study will allow the clinical validation of the safety and safety of the investigation software Clinicgram Euclides.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The subject must give written informed consent prior to any procedure related to the clinical investigation.
✓. Adult person 18 years of age or older.
✓. The subject has an external skin lesion whose length and width can be measured with a 15-centimeter ruler.
✓. The subject's external skin lesion can be measured with a perpendicular camera approach (90 degrees).
✓. The subject has an external skin lesion located in an area that does not include an edge or curvature of the body, and that has no parts hidden by any device or treatment.
✓. The subject has one or more isolated skin lesion(s) that allows for an individual capture and analysis process for each lesion.
✓. Subjects are able to tolerate changes in position for at least 2 minutes in the area where the skin lesion is located.
✓. Subjects can hold still, or not be prevented by pain from having still, for at least 10 seconds for the taking of the skin lesion photograph.

Exclusion criteria

✕. The subject is currently participating in another clinical investigation.
✕. Pregnant or breastfeeding women. Subjects who have medical, social, or psychological conditions that, in the opinion of the investigator, could limit the subject's ability to participate in the investigation or impact the scientific robustness of the clinical investigation results.

What they're measuring

Agreement of the skin lesion area measurements between two methods of routine clinical practice and the investigational software Clinicgram Euclides.

Timeframe: 1 day

Reproducibility of Clinicgram Euclides in the automatic calculation of skin lesion areas using different mobile devices.

Timeframe: 1 day

Repeatability of Clinicgram Euclides in the automatic calculation of skin lesion areas between two measurements performed by the same investigator.

Timeframe: 1 day

Trial details

NCT IDNCT05729334

SponsorSkilled Skin S.L.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-12

View on ClinicalTrials.gov More Skin Lesion trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The subject must give written informed consent prior to any procedure related to the clinical investigation.
✓. Adult person 18 years of age or older.
✓. The subject has an external skin lesion whose length and width can be measured with a 15-centimeter ruler.
✓. The subject's external skin lesion can be measured with a perpendicular camera approach (90 degrees).
✓. The subject has an external skin lesion located in an area that does not include an edge or curvature of the body, and that has no parts hidden by any device or treatment.
✓. The subject has one or more isolated skin lesion(s) that allows for an individual capture and analysis process for each lesion.
✓. Subjects are able to tolerate changes in position for at least 2 minutes in the area where the skin lesion is located.
✓. Subjects can hold still, or not be prevented by pain from having still, for at least 10 seconds for the taking of the skin lesion photograph.

Exclusion criteria

✕. The subject is currently participating in another clinical investigation.
✕. Pregnant or breastfeeding women. Subjects who have medical, social, or psychological conditions that, in the opinion of the investigator, could limit the subject's ability to participate in the investigation or impact the scientific robustness of the clinical investigation results.

What they're measuring

Agreement of the skin lesion area measurements between two methods of routine clinical practice and the investigational software Clinicgram Euclides.

Timeframe: 1 day

Reproducibility of Clinicgram Euclides in the automatic calculation of skin lesion areas using different mobile devices.

Timeframe: 1 day

Repeatability of Clinicgram Euclides in the automatic calculation of skin lesion areas between two measurements performed by the same investigator.

Timeframe: 1 day