An upcoming clinical trial aims to assess the safety and effectiveness of Quinton Medical Nasal Health Baby® in managing nasal congestion and associated symptoms in infants and toddlers. This post-market clinical follow-up (PMCF) will focus on conditions such as flu symptoms, the common cold, allergic rhinitis, and rhinosinusitis. Sponsored by Laboratoires Quinton International S.L., the study is not yet recruiting participants as of December 3, 2025.
What changed?
The scheduled clinical trial will investigate the potential of an isotonic saline-based medical device, Quinton Medical Nasal Health Baby®, in offering relief from nasal congestion in young children. This launch is significant in meeting market surveillance requirements under the Medical Device Regulation (MDR) while addressing the critical need to ensure safety and clinical efficacy for pediatric use.
Study details
Laboratoires Quinton International S.L. has planned this PMCF study to further substantiate the performance claims of their device. The study will focus on the following conditions:
- Nasal congestion
- Symptoms of flu
- Common colds
- Allergic rhinitis
- Rhinosinusitis
Quinton Medical Nasal Health Baby® is an isotonic saline solution specifically developed to support nasal health in infants and toddlers. The device’s non-pharmacological nature makes it a valuable management option for relief of nasal symptoms without the systemic effects of medication.
The trial will meet regulatory requirements for clinical evaluation by providing real-world evidence to support the device’s intended purpose. However, as the trial has yet to begin recruitment, further updates are awaited for the enrollment timeline and key study milestones.
What are the implications?
This PMCF study reinforces the ongoing commitment to safety and performance monitoring required by the EU MDR. If the study findings validate the intended benefits, Quinton Medical Nasal Health Baby® may strengthen its position as a reliable pediatric nasal care solution. This could have an important impact on healthcare professionals and caregivers seeking safe and effective options for managing nasal congestion in infants.
Frequently Asked Questions
- What conditions is the study targeting?
The target conditions are nasal congestion, flu symptoms, common colds, allergic rhinitis, and rhinosinusitis in infants and toddlers. - What is the device being studied?
The device is Quinton Medical Nasal Health Baby®, an isotonic saline solution designed for pediatric use. - Who sponsors this study?
Laboratoires Quinton International S.L. is the sponsor of this clinical trial. - When will the trial begin?
The study is currently not recruiting. Updates on recruitment timelines are pending.
Conclusion
The forthcoming PMCF study will provide critical evidence to validate the safety and effectiveness of Quinton Medical Nasal Health Baby® for managing nasal symptoms in young children. Regulatory and clinical professionals should monitor the trial’s progress for further insights into the device’s performance metrics.
Disclaimer
The information provided here is for informational purposes only and should not be considered as legal or regulatory advice. Professionals should consult appropriate guidelines for decision-making.
Full announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07257224?term=medical+device