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Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

NCT05494346 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-09-25

No results posted yet for this study

Summary

The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.

Conditions

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

Interventions

DEVICE

Measurement of peak nasal flow.

Peak nasal flow measurements will be performed before and after the first use of the spray at D0, as well as after the use of the spray at the medical office at D3 (only for arm A).

Sponsors & Collaborators

  • EVAMED

    collaborator OTHER

  • Laboratoires Gilbert

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-23
Primary Completion
2026-04-18
Completion
2026-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05494346 on ClinicalTrials.gov