Published on: October 5, 2025
A new clinical trial is underway comparing surgical outcomes and time efficiency between two distinct suturing methods used in renal cancer surgeries. Sponsored by the Brazilian Institute of Robotic Surgery, this study examines the performance of cortical and medullary two-layer suturing against medullary-only single-layer suturing techniques—a critical advancement for healthcare professionals and regulatory stakeholders evaluating medical device innovations.
What suturing methods are being studied?
This trial investigates two approaches to suturing during renal cell cancer (RCC) surgeries. The first method, cortical and medullary suturing, uses a two-layer technique combined with hemostatic agents. The second approach relies solely on medullary suturing, a single-layer application. Both utilize specialized sutures designed for precise tissue closure.
The study aims to establish evidence on the comparative effectiveness of these methods, focusing on safety, surgical time, and long-term outcomes in RCC patients.
How do efficiency and outcomes compare?
The trial will assess critical performance metrics, including:
- Surgical time: Comparing durations for both techniques to improve procedural efficiency.
- Post-surgical outcomes: Evaluating healing rates, complication frequencies, and effectiveness in minimizing bleeding.
- Patient quality of care: Determining whether device and procedural enhancements improve recovery experiences.
The integration of hemostatic agents in the two-layer method is expected to mitigate intraoperative bleeding, enhancing surgical precision and safety. However, whether these benefits outweigh the simplicity and reduced application time of the single-layer method remains to be seen.
These findings will inform surgeons, device manufacturers, and regulatory professionals, providing evidence-based insights for optimal procedural choices.
What information is available about the trial?
The Cortex Clinical Trial is currently recruiting participants. It is sponsored by the Brazilian Institute of Robotic Surgery, a respected organization focused on advancing minimally invasive surgical technologies.
The ClinicalTrials.gov page, accessible here, provides detailed information about its design, interventions, and expected endpoints.
Eligible RCC patients will undergo detailed screening to ensure compliance with trial conditions. A multidisciplinary team is conducting the study under rigorous ethical and regulatory oversight.
This research aligns with global efforts to improve medical device applications in surgery, adhering to MDR Annex XIV performance and safety standards.
Frequently Asked Questions
1. Who is sponsoring the trial?
The Brazilian Institute of Robotic Surgery sponsors the trial, emphasizing innovative approaches to kidney cancer surgeries.
2. What devices are involved?
Both procedural methods use specialized sutures, with the two-layer approach additionally incorporating hemostatic agents to control bleeding.
3. How does this benefit regulatory and clinical teams?
Findings will guide decision-making on medical device performance, safety, and intended surgical indications.
4. Where can I find more details?
Additional details, including eligibility criteria and outcomes, can be found on its ClinicalTrials.gov listing available here.
Conclusion
The Cortex Clinical Trial is a promising research initiative addressing critical questions in RCC surgery techniques. By comparing two-layer and single-layer suturing strategies, this study will help advance procedural efficiency and enhance post-surgical outcomes. Stakeholders from clinical, regulatory, and device development fields should closely monitor its developments to integrate findings into their practices.
Disclaimer
This material is provided for informational purposes only and does not constitute legal or regulatory advice. Professionals should consult relevant guidelines before applying any insights.
Announcement and Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07190638?term=medical+device