Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot (NCT06291142) | Clinical Trial Compass
CompletedNot Applicable
Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot
United Kingdom112 participantsStarted 2023-11-22
Plain-language 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.
Who can participate
Age range
6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Image Acquisition:
* Children (aged between 6-17 years) and adults (aged 18 years and above) with Raynaud's phenomenon or a SSc- spectrum disorder.
Qualitative aspect:
* Rheumatologists, vascular technicians, specialist nurses, or similar rheumatology trained professionals
* Patients with Raynaud's phenomenon and/or a SSc-spectrum disorder.
* Adults ages 18 years and over.
Exclusion Criteria:
* (Patients; image acquisition and skin tone study). Diabetes
* (Healthy controls). Requirement for vasoactive therapies
* (Healthy controls). Any condition known to affect the vasculature e.g. unregulated hypertension
* (All groups). Any disorder limiting the ability to provide informed consent or to comply with study requirements.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.