ACERS
Research type
Research Study
Full title
Automated Capillaroscopy Evaluation in Raynaud's and SSc (ACERS): Supporting early diagnostic decision-making in the general rheumatology clinic
IRAS ID
324900
Contact name
Ariane Herrick
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
0 years, 9 months, 30 days
Research summary
This is a multi-centre feasibility and efficacy study of the CapilyticsAcquisition app, a novel nailfold capillaroscopy image acquisition and analysis software designed to support diagnostic decision-making in systemic sclerosis (SSc).
The study will assess the system's performance in routine clinical settings (feasibility) and its ability to distinguish between capillary changes in patients with primary Raynaud’s phenomenon and those with SSc-spectrum disorders (efficacy). Automated analysis results will be compared against expert clinical diagnoses.
A total of 315 participants will be recruited from up to seven NHS rheumatology clinics. Each participant will attend a single visit involving nailfold capillaroscopy imaging using the CapilyticsAcquisition system, collection of medical and demographic data, and completion of a short questionnaire. Healthcare professionals will review the images and software-generated reports to assess clinical relevance and functionality.
A subset of participants and all participating healthcare professionals will be invited to provide qualitative feedback through interviews or focus groups. In addition, independent expert review of patient images will be carried out to further evaluate diagnostic accuracy.
REC name
West of Scotland REC 4
REC reference
25/WS/0142
Date of REC Opinion
16 Oct 2025
REC opinion
Further Information Favourable Opinion