NCT06580210

Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction

Prospective Multicenter Clinical Investigation to Evaluate the Performance and the Safety of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert (DEMECA)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 114 (estimated)
• Sponsor: Laboratoires Gilbert · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert. The study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period.

Conditions

• Acute Rhinitis
• Nasal Obstruction
• Rhinosinusitis
• Rhinopharyngitis
• Allergic Rhinitis

Timeline

• Start date: 2024-10-22
• Primary completion: 2026-05-30
• Completion: 2026-06-07
• First posted: 2024-08-30
• Last updated: 2025-11-21

Locations

3 sites across 1 country: France