A recent clinical trial sponsored by Assiut University is set to explore the efficacy of Shear Wave Elastography (SWE) in detecting enthesitis in patients with Psoriatic Arthritis (PsA). The study will also assess the relationship between SIRT2 protein expression and disease activity. Although not yet recruiting, this trial highlights the growing potential of advanced ultrasound technologies in rheumatology. Medical device, clinical, and regulatory teams are advised to monitor this development closely for its implications on patient care and device approval processes.
What is the study about?
The clinical trial aims to validate the use of Musculoskeletal Ultrasound Devices leveraging SWE technology to detect enthesitis, a hallmark feature of Psoriatic Arthritis. Enthesitis refers to inflammation at the insertion sites of tendons or ligaments. Accurate detection is crucial for timely intervention. The researchers will also investigate the role of SIRT2, a protein associated with cellular regulation, in disease progression and activity levels.
The trial is documented on ClinicalTrials.gov under the identifier NCT07188688. It is currently listed as not yet recruiting, suggesting it is in the preparatory phase. This study underscores the integration of imaging advancements with molecular biomarkers to unravel new therapeutic insights.
How does Shear Wave Elastography work?
Shear Wave Elastography is an advanced ultrasound imaging technique that measures tissue stiffness. By emitting focused sound waves into the target tissue, the device captures the resulting shear waves to create a quantitative stiffness map. This objective metric is particularly beneficial for evaluating soft tissue disorders like enthesitis, where inflammation leads to structural changes.
The Musculoskeletal Ultrasound Devices utilized in this study are designed for high-resolution imaging, allowing clinicians to detect subtle changes in joint and tissue structures. Such precision supports both diagnostic accuracy and disease monitoring, critical in minimizing long-term complications of PsA.
What are the potential implications?
The trial has significant implications for both clinical practice and regulatory trajectories. By linking SWE findings with SIRT2 expression and disease activity, the study may pave the way for more personalized approaches in diagnosing and treating PsA. Understanding these relationships could lead to earlier detection and tailored intervention strategies, potentially improving patient outcomes.
If successful, this trial could influence future device classifications, guidance on imaging diagnostics, and post-market surveillance standards for medical devices in rheumatological care. Regulatory stakeholders should also take note of potential new data requirements arising from such integrated biomarker-based diagnostics.
FAQ
- What is the purpose of Shear Wave Elastography in this trial?
To evaluate its effectiveness in detecting soft tissue inflammation, specifically enthesitis, in PsA patients. - What is SIRT2, and why is it important?
SIRT2 is a protein that regulates cellular functions. Its expression levels might correlate with PsA severity and progression. - When will the trial begin recruiting?
As of the latest information, the study is listed as not yet recruiting. No specific recruitment start date is available. - Who is sponsoring the study?
The trial is sponsored by Assiut University, emphasizing collaboration between academic research and clinical innovation.
Conclusion and next steps
This trial represents a critical step in merging ultrasound innovation with biomarker research. Regulatory and clinical teams should consider the potential implications of this study for device registration processes and future imaging standards. Keeping abreast of such advancements will ensure readiness for emerging clinical applications and regulatory criteria.
Disclaimer
This content is for informational purposes and is not intended to provide legal or clinical advice. Always consult professional regulatory guidance.
Further information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07188688?term=medical+device