Zagazig University has launched a clinical trial investigating the effectiveness of combining a flexible and navigable suction sheath (FANS) with flexible ureteroscopy (FURS) in managing lower calyceal kidney stones. The study aims to assess outcomes such as performance, safety, and patient impact. This development could provide clinical, regulatory, and quality teams with valuable data concerning advancements in kidney stone treatment devices. The trial is actively recruiting participants as of November 20, 2025.
In this article:
- What changed?
- Key details about the study
- How is device performance being evaluated?
- FAQs
- Conclusion
- Disclaimer
- Official link for more information
What changed?
This trial represents an important focus on combining device innovation with flexible ureteroscopy for addressing lower calyceal stones. By actively recruiting participants, researchers aim to develop evidence-based findings relevant to clinical device usage.
Key details about the study
Study sponsors and scope
Zagazig University is sponsoring the clinical trial, defined under the conditions of kidney stone and kidney calculi management. The study will explore how FANS combined with FURS contributes to improvements in treating lower calyceal stones.
Intervention overview
The intervention uses a flexible and navigable suction sheath alongside flexible ureteroscopy. These tools are intended to enhance the precision and effectiveness of removing lower calyceal kidney stones.
Recruitment update
The study is actively seeking eligible participants to provide robust data on the clinical application of these devices.
How is device performance being evaluated?
Key metrics will include:
- Safety outcomes such as complication rates
- Efficacy metrics including stone clearance rates
- Usability for clinicians, focusing on the ease of deployment and navigation
The trial follows stringent regulatory compliance aligned with medical device directives that ensure data integrity and reliability.
FAQs
- What is the purpose of this trial?
The purpose is to assess the performance and safety of FANS combined with FURS for lower calyceal kidney stones. - Where is the trial being conducted?
It is sponsored and conducted by Zagazig University. - How does the device improve current treatment methods?
The suction sheath aims to enhance control during procedures, and flexible ureteroscopy extends access to challenging areas.
Conclusion
This trial could pave the way for improved kidney stone management by evaluating the utility of combining flexible suction sheath technology with ureteroscopy. Clinical teams should monitor findings closely to stay informed about potential advancements in treatment methods.
Disclaimer
This content is intended for professional use and informational purposes only. It does not constitute legal or medical device guidance. Always consult official regulatory sources when making compliance decisions.
Official link for more information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07238803?term=medical+device