Published: November 18, 2025
Medtronic’s latest clinical trial aims to explore oxygen saturation monitoring with its investigational Nellcor™ device under various conditions, including sitting and walking activities. Regulatory, clinical, and quality teams may find this study particularly relevant as it tackles real-world applications of medical device performance monitoring for oxygen levels.
In this article
- What is the study about?
- Who conducts this research?
- What are the implications?
- FAQ
- Conclusion
- Disclaimer
- Additional Information
What is the study about?
The clinical trial, titled Nellcor™ Investigational Device Sitting-Walking Study, focuses on understanding oxygen saturation during everyday activities, such as sitting and walking. Monitoring oxygen levels in these scenarios is critical for evaluating device performance in real-life settings. The study uses the Nellcor™ device, designed to provide accurate oxygen saturation measurements.
The study is listed as “Not yet recruiting,” indicating that it is in its preparatory phase. Researchers and sponsors are likely finalizing details to ensure compliance with clinical trial regulations. This phase is crucial for collecting reliable data once recruitment begins.
Who conducts this research?
The trial is sponsored by Medtronic’s Minimally Invasive Therapies Group (MITG). Medtronic is a global leader in medical technology, committed to advancing patient care through innovation. The company’s focus on real-world device performance aligns with its regulatory commitments and patient-focused mission.
Clinical research conducted by Medtronic is often held to rigorous regulatory standards to ensure safety, efficacy, and compliance with global medical device requirements.
What are the implications?
Understanding oxygen saturation dynamics in different physical states is valuable for a range of clinical applications, including respiratory, cardiovascular, and critical care. The findings from this study could strengthen Medtronic’s regulatory submissions or product labeling by providing data on device reliability under variable conditions.
For healthcare providers, the study may enhance understanding of the device’s usability, which could aid in decision-making for patient care. On the regulatory side, this evidence serves as critical documentation for the device’s intended purpose and safety profile.
It is worth noting that studies like these are integral to building a comprehensive safety and performance dossier, as required by international medical device regulations such as the EU MDR.
FAQ
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What is the primary goal of this study? The study aims to evaluate oxygen saturation levels during sitting and walking using the Nellcor™ device, providing data on its real-world performance.
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Who is eligible to participate? As the study is not yet recruiting, eligibility criteria have not been finalized. They will likely depend on the study’s protocol once approved.
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Where can I find more details? Visit the trial’s ClinicalTrials.gov page for official updates:
Conclusion
Medtronic’s investigational study highlights the company’s commitment to advancing medical technologies for monitoring oxygen saturation during real-life activities. Regulatory, clinical, and quality professionals should monitor this trial for updates as it progresses. Understanding device performance in such scenarios could have far-reaching implications for patient care and regulatory practices.
Disclaimer
This article is intended for informational purposes only and is not legal or medical advice. Please consult appropriate professionals or regulatory bodies for guidance on clinical trial participation or compliance.
Additional Information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07234279?term=medical+device