Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot

Summary

The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions. The main questions it aims to answer are:

* Can a range of healthcare professionals, including non-specialists, use the capillaroscopy image acquisition system to take high quality images that can be used to create a clinical report?
* Can the investigators collect user and patient feedback on the usability of the capillaroscopy system, to help develop the software and to develop the clinical report
* Which microscope light source, from four different light wavelengths is better to see the blood vessels in skin with more melanin content.

Participants will be asked to attend a single clinic visit where they will undergo a brief, non-invasive nailfold capillaroscopy examination, using the software-guided capillaroscopy system.

Participants and rheumatology healthcare professionals will be invited to take part in one or more focus groups and interviews, to collect feedback and to contribute to the development of the image acquisition software and the clinical report.

Conditions

• Systemic Sclerosis
• Raynaud Phenomenon

Interventions

DEVICE

Observation - Nailfold capillaroscopy

Nailfold capillaroscopy examination

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Royal Bolton Hospital NHS Foundation Trust

  collaborator OTHER

• Alder Hey Children's NHS Foundation Trust

  collaborator OTHER

• University Hospitals of Morecambe Bay NHS Trust

  collaborator OTHER

• Stockport NHS Foundation Trust

  collaborator OTHER

• Medway NHS Foundation Trust

  collaborator OTHER

• Northern Care Alliance NHS Foundation Trust

  collaborator OTHER

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• University of Manchester

  lead OTHER

Principal Investigators

• Ariane E Herrick, MD, FRCP · The University of Manchester

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-22

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• United Kingdom

Study Locations