Systemic sclerosis spectrum disorders Musculoskeletal Diseases
Conditions
Interventions
This clinical investigation is a prospective, multi-centre study evaluating the Capilytics AI-based system developed for nailfold capillaroscopy image acquisition and analysis.
Following the consent
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Age
6 Years to 100 Years
Inclusion criteria
Inclusion criteria: Patient participants: 1. 15 participants per site with established SSc (SSc)-spectrum disorders 2. Adults over 18 years 3. All should fulfil the 2013 ACR/EULAR classification criteria for SSc Children over 6 years and under 18 years of age (at Alder Hey only): 1. All should fulfil the 2013 ACR/EULAR classification criteria for SSc, OR have juvenile dermatomyositis (JDM) 2. Patients with overlap syndromes may be included, as long as they fulfil the criteria for either SSc or JDM. 1. 30 participants per site presenting with Raynaud’s phenomenon but no previous diagnosis of SSc. 2. Adults over 18 years 3. Patients who are referred for capillaroscopy with Raynaud’s phenomenon, and either a new referral or first seen (at the participating hospital) within the last 2 years Children over 6 years and under 18 years of age (at Alder Hey only): Referred primarily with Raynaud’s phenomenon and either a new referral or first seen (at Alder Hey) within the last 2 years Healthcare Professional participants (qualitative research aspect only): 1. Rheumatologists, vascular technicians, specialist nurses, or similar rheumatology-trained professionals 2. Experience with the use of the Capilytics system during this study.
Exclusion criteria
Exclusion criteria: 1. 15 participants per site with established SSc (SSc)-spectrum disorders: 2. Any reason why nailfold capillaroscopy would be difficult, such as marked finger contractures or painful digital ulcers 3. Diabetes 4. Any disorder limiting the ability to provide informed consent or comply with the study requirements 30 participants per site presenting with Raynaud’s phenomenon but no previous diagnosis of SSc: 1. A defined connective tissue disease (including JDM), vasculitis or inflammatory arthritis (note patients with Very Early Diagnosis of SSc [VEDOSS] may be included, but not patients who fulfil the 2013 classification criteria for SSc or who score 7 or more points on the classification criteria without nailfold capillaroscopy, i.e. if nailfold capillaroscopy is abnormal, they would fulfil the criteria) 2. Presence of a known secondary cause for Raynaud’s phenomenon 3. Any reason why nailfold capillaroscopy would be difficult, e.g. finger deformities 4. Diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of this project are: - Proportion of attempted investigations completed successfully, acquiring diagnostic quality images and generating a valid clinical report (feasibility); - System Usability Score averaged over all users (feasibility); - Sensitivity of the device in detecting disease-related vessel abnormalities (efficacy); - Specificity of the device in detecting disease-related vessel abnormalities (efficacy); - To demonstrate that the CapilyticsAcquisition device is safe and performs as expected under normal conditions of use. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints of this project are: - Average per-patient duration of the investigation; - Qualitative data from users on the strengths and weaknesses of the system; - Qualitative data from patients on the acceptability of the investigation; - Analysis of the performance of individual software system components. | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactSarah Wilkinson
Outcome results
None listed