On October 5, 2025, updates concerning the clinical trial status of a nasal spray device designed to alleviate nasal dryness were released. The device, named “Spray pompe nasal confort,” combines isotonic seawater and hyaluronic acid to offer innovative relief for individuals experiencing nasal discomfort. Sponsored by YSLab and Eclevar Medtech, this trial remains under a “Not yet recruiting” status, signaling upcoming opportunities for participation from qualified clinicians and study volunteers.
For healthcare professionals, regulatory specialists, and clinical teams, this development offers strategic insight into upcoming advancements in nasal care technologies. Below, navigate through key sections to understand the trial and its implications better:
- What are the trial details?
- How is the device designed?
- Who are the trial sponsors?
- FAQs
- Conclusion
- Disclaimer
- Full announcement link
What are the trial details?
The clinical trial is listed under ClinicalTrials.gov with the identifier NCT07204158. It aims to evaluate the performance and safety of a medical device developed for nasal dryness relief. As of October 2025, recruitment for the study has not commenced. Once recruiting begins, professional investigators and participants will play critical roles in determining the device’s effectiveness and compliance with MDR regulatory standards.
How is the device designed?
The device, named “Spray pompe nasal confort,” employs a combination of isotonic seawater and hyaluronic acid. Isotonic seawater serves as a hydrating agent by mimicking natural body fluids, while hyaluronic acid enhances moisture retention and tissue repair. Together, these ingredients aim to alleviate nasal dryness symptoms effectively.
According to the sponsors, this innovative blend may offer an enhanced user experience compared to traditional saline sprays. However, clinical trial results will determine whether the device meets its intended performance and safety outcomes.
Who are the trial sponsors?
The trial is sponsored by YSLab, a research-focused company dedicated to developing wellness and healthcare solutions, and Eclevar Medtech, which specializes in clinical trial management and medtech innovations. Their collaboration highlights a strategic approach to medical device development and regulatory compliance.
Both sponsors have expressed commitment to ensuring the trial adheres rigorously to quality and safety standards outlined in MDR Annex XIV, which emphasizes clinical evaluations’ importance in determining medical devices’ safe use.
FAQs
1. What is the current trial status?
The trial is “Not yet recruiting,” according to ClinicalTrials.gov.
2. What does isotonic seawater do?
Isotonic seawater mimics the body’s natural fluids, providing hydration and cleansing benefits to the nasal mucosa.
3. How does hyaluronic acid help with nasal dryness?
Hyaluronic acid retains moisture and aids in tissue repair, making it effective for alleviating nasal dryness.
4. What are the sponsors’ roles?
YSLab and Eclevar Medtech collaborate to oversee device development, regulatory adherence, and trial execution.
Conclusion
The upcoming clinical evaluation of “Spray pompe nasal confort” brings promising advancements to nasal care technologies. For clinical teams and regulatory specialists, involvement in this trial offers an opportunity to contribute significantly to understanding its therapeutic value and compliance with medical device standards.
Disclaimer
This blog post provides information for professional audiences. It is not legal or clinical advice. Readers should consult official trial sponsors and regulatory bodies for detailed guidance.
Full announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07204158?term=medical+device