The results of a single-arm clinical trial investigating the medical device UZit® for symptomatic chronic venous disease have been published. Sponsored by Universidade do Porto, the trial supports the feasibility, efficacy, and safety of this device. Clinical, regulatory, and quality teams now have additional evidence on treatment options for patients with venous insufficiency or related conditions.
What was the goal of the study?
The primary objective of this trial was to evaluate the feasibility, performance, and safety profile of UZit® in patients with symptoms of chronic venous disease. Chronic venous disease can result in significant discomfort, swelling, and potential complications when left unmanaged. Devices like UZit® aim to address these issues by improving venous drainage and alleviating symptoms.
Conducted under rigorous clinical conditions, the trial enrolled patients diagnosed with venous insufficiency of the leg. The single-arm design focused on the device’s real-world applicability without a control group comparison.
What did the trial reveal?
Clinical performance
Participants experienced notable symptomatic relief following treatment with UZit®. The device demonstrated its ability to facilitate drainage and enhance overall venous function. No significant adverse events were reported, reinforcing its safety.
Safety profile
Patient safety was a critical endpoint of the study. Monitoring throughout the trial indicated no device-related complications, confirming the safety claims of UZit®.
Regulatory implications
These findings provide a robust foundation for future submissions to regulatory bodies. The documentation from this study supports claims regarding the device’s safety and performance, aligning with Medical Device Regulation (MDR) requirements in Europe.
What does this mean for regulatory teams?
Regulatory teams should note that this study offers strong evidence for UZit®’s intended use and safety profile. Integrating these results into regulatory filings can enhance product positioning in an increasingly data-driven market.
Furthermore, quality teams can leverage the methodology and outcomes as benchmarks for future device performance evaluations. Close alignment with clinical evidence may expedite pathways toward certification and broader adoption.
FAQs
- What condition does UZit® treat?
UZit® is designed for patients with symptomatic chronic venous disease, including venous insufficiency of the leg. - Was this trial randomized?
No, the study used a single-arm design without a control group. - Were adverse events reported?
No significant adverse events were observed during the trial.
Conclusion
The clinical trial results highlight UZit® as a feasible, safe, and effective medical device for managing chronic venous disease. Healthcare professionals and regulatory teams can view these outcomes as a critical step toward broader market validation and utilization.
Disclaimer
This article is for informational purposes only and is not intended as legal or regulatory advice. Regulatory teams should consult local requirements before proceeding with approvals.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07236307?term=medical+device