Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 5:13 PM
Study NCT ID:
NCT05729334
Status:
COMPLETED
Last Update Posted:
2023-04-14
First Post:
2023-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
Sponsor:
Skilled Skin S.L.
Organization:
Study Overview
Official Title:
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Detailed Description:
The aim of the clinical investigation EUCLIDES-01 is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three skin lesion area measurement methods:
* Ruler using the Kundin method,
* Investigational software Clinicgram Euclides
* Digital planimetry with Adobe Photoshop
Clinicgram Euclides is a software that allows automatic calculation of skin lesion areas using a mobile device. It has two modes of operation (Euclides 2D and Euclides 3D).
The sample size is 65 subjects. Up to three skin lesions can be included from the same subject. For this reason, the number of subjects may be smaller if more than one skin lesion is measured in certain subjects.
EUCLIDES-01 is a pre-market, prospective, single-center, non-randomized clinical investigation with one arm of subjects intended to collect skin lesion area data for the comparison of the agreement among the results obtained between the three above-mentioned skin lesion area measurement methods.
No patient follow-up.
* Ruler using the Kundin method,
* Investigational software Clinicgram Euclides
* Digital planimetry with Adobe Photoshop
Clinicgram Euclides is a software that allows automatic calculation of skin lesion areas using a mobile device. It has two modes of operation (Euclides 2D and Euclides 3D).
The sample size is 65 subjects. Up to three skin lesions can be included from the same subject. For this reason, the number of subjects may be smaller if more than one skin lesion is measured in certain subjects.
EUCLIDES-01 is a pre-market, prospective, single-center, non-randomized clinical investigation with one arm of subjects intended to collect skin lesion area data for the comparison of the agreement among the results obtained between the three above-mentioned skin lesion area measurement methods.
No patient follow-up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: