NCT03399721

Investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the Treatment of Non Allergic Rhinitis

A Clinical Investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the Treatment of Non Allergic Rhinitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Chordate Medical · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an interventional, multicenter, double-blind, placebo-controlled trial in which patients diagnosed with non-allergic rhinitis will be randomized to either intranasal stimulation, or placebo treatment with the Chordate System at two occasions.

Detailed description

This is a double-blind, placebo-controlled, multi-center study in which patients diagnosed with non-allergic rhinitis will receive intranasal stimulation with the Chordate System at two occasions. Objectives are to evaluate the efficacy of the procedure in reducing disease specific symptoms such as nasal congestion, rhinorrhea, nasal itching and sneezing, but also to investigate the influence on quality of life, safety and tolerability.

Conditions

• Nasal Congestion
• Non-allergic Rhinitis

Interventions

Type	Name	Description
DEVICE	Chordate S101	Active treatment: The controller creates air-mediated kinetic oscillations with regulated pressure and frequency during a preset treatment time
DEVICE	Chordate S101 Placebo	Placebo treatment: Placebo treatment is similar to active treatment, but with no oscillations. It is difficult to discern any difference between active and placebo treatment.

Timeline

• Start date: 2018-05-07
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2018-01-16
• Last updated: 2023-09-22

Locations

13 sites across 6 countries: Czechia, Finland, Greece, Italy, Netherlands, United Kingdom