Non-invasive prospective Pilot in a Live Environment for the Improvement of the diagnosis of skin pathologies in primary care and dermatology - LEGIT.HEALTH_SAN_2024

Study identification

• EU PAS number:
  EUPAS1000000911
• Study ID:
  1000000911
• Official title and acronym:
  Non-invasive prospective Pilot in a Live Environment for the Improvement of the diagnosis of skin pathologies in primary care and dermatology - LEGIT.HEALTH_SAN_2024
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Title: Non-invasive prospective Pilot in a Live Environment for the Improvement of the diagnosis of skin pathologies in primary care and dermatology; Protocol Code: LEGIT.HEALTH_SAN_2024; ; Study Design & Objectives; This prospective, observational, cross-sectional validation study evaluated whether the AI-based medical device, Legit.Health Plus (v1.1.0.0) improves diagnostic accuracy for multiple dermatological conditions. The primary objective was to validate that the device increases true diagnostic accuracy among Healthcare Professionals (HCPs). Secondary objectives included validating the potential for reducing referrals and increasing remote case management (teledermatology).; ; Methods; Sixteen healthcare professionals (10 primary care practitioners, 6 dermatologists) were recruited. Each participant evaluated 29 validated images covering 13 distinct pathologies, including Melanoma, Psoriasis, Dermatitis, Tinea, and Acne. A pre-post design was utilised: HCPs diagnosed cases first without assistance, and subsequently reviewed the AI’s analysis (top 5 diagnoses with confidence levels) to confirm or revise their decision. Participants also assessed if the case required specialist referral or could be managed remotely.; ; Key Results; Overall diagnostic accuracy significantly increased from 68.08% to 88.78% with the device (p < 0.0001).; - Primary Care: Accuracy improved markedly from 62.90% to 89.92% (+27.02%).; - Dermatologists: Accuracy improved from 76.47% to 86.93% (+10.46%).; - Referrals: 58.1% of cases were deemed not to require a specialist referral.; - Remote Management: 55.11% of cases could be effectively handled remotely.; ; Conclusion; The device significantly enhanced diagnostic accuracy and efficiency across specialties. It demonstrated strong potential for triage, reducing unnecessary referrals, and facilitating remote consultations. No adverse events were reported.; ; Dates: 01/06/2024 – 10/10/2024
• Study status:
  Finalised

Research institutions and networks

Institutions

AI Labs Group S.L. (Legit.Health)

Spain

Study timelines

Date when funding contract was signed

Planned:15/05/2024

Actual:15/05/2024

Study start date

Planned:01/06/2024

Actual:01/06/2024

Date of final study report

Planned:10/10/2024

Actual:10/10/2024

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable