Stanford University is set to initiate a clinical evaluation of the Origin Intubation System, focusing on device usability. This news highlights their ongoing commitment to advancing medical device innovation and safety. While this trial is not yet recruiting, stakeholders in clinical, quality, and regulatory fields should monitor its progress.
What is this clinical trial about?
The clinical trial, sponsored by Stanford University, aims to evaluate the usability of the Origin Intubation System, a medical device designed for airway management. While detailed performance data is not available yet, the study’s primary focus is on assessing how the device performs under clinical conditions. The Origin Intubation System intends to provide optimized functionality, reliability, and safety during intubation procedures.
The trial will serve as a critical step in establishing evidence for the device’s suitability for medical applications while ensuring compliance with regulatory standards for medical devices. It is essential for manufacturers and healthcare providers to understand usability aspects as part of the device’s evaluation.
Who should follow this development?
This development is particularly relevant for clinical teams, quality assurance professionals, regulatory experts, and device manufacturers. As usability becomes increasingly scrutinized under regulations like MDR Annex XIV, this trial offers insights into how academic and clinical entities are addressing usability in new device evaluations. Medical device companies that focus on airway management systems should consider following these findings.
Additionally, healthcare professionals specializing in anesthesiology or emergency care may find this trial’s outcomes valuable for their practice.
What are the regulatory implications?
Clinical trials focusing on device usability align with global regulatory frameworks that emphasize safety and performance. Regulatory authorities often require detailed evaluations to demonstrate compliance with essential requirements. This trial will likely yield significant insights into achieving regulatory clearance for similar devices.
Sponsors and stakeholders should reference MDR Annex XIV to understand expectations for intended performance, usability validation, and the necessity for substantiated safety data. As Stanford University progresses toward activation, the trial’s results could provide a template for advanced methodologies in usability testing.
FAQs
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What is the expected timeline for recruitment?
The trial is listed as “not yet recruiting.” No specific recruitment timeline has been published.
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Where can we access detailed trial protocols?
Detailed protocols will likely become available on ClinicalTrials.gov once recruitment begins.
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Why focus on device usability?
Usability directly impacts patient outcomes and safety during critical procedures. Assessing this factor ensures the device meets practical and regulatory standards.
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What entity is driving this study?
Stanford University is the study’s sponsor, reflecting their involvement in innovative medical device research.
Conclusion and key takeaways
Stanford University is preparing to launch a pivotal clinical trial to evaluate the Origin Intubation System. While recruitment is yet to begin, stakeholders should familiarize themselves with the device’s usability focus. This study could pave the way for future advancements in airway management devices while setting standards for device usability evaluations under MDR and similar regulations.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or professional regulatory advice. Readers should consult appropriate regulatory professionals regarding specific compliance matters.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07189182?term=medical+device