NCT06773013
Completed
N/A
Safety and Effectiveness of Sonu Acoustic Resonance Therapy for the Treatment of Pediatric Patients With Moderate to Severe Nasal Congestion.
Third Wave Therapeutics1 site in 1 country31 target enrollmentJanuary 9, 2025
ConditionsNasal Congestion and Inflammations
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Nasal Congestion and Inflammations
- Sponsor
- Third Wave Therapeutics
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Serious adverse events
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
To demonstrate the safety and effectiveness of Sonu for the treatment of pediatric patients with moderate to severe nasal congestion.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pediatric subjects between the ages of 12 to 21 years
- •Present with symptoms of nasal congestion for 1 month or more prior to treatment
- •Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening
Exclusion Criteria
- •Head, nasal or sinus surgery within 3 months
- •Sinus infection diagnosed within the last month, or rhinitis medicamentosa
- •Documented history of nasal polyposis or mass
- •Pregnancy
Outcomes
Primary Outcomes
Serious adverse events
Time Frame: 2 weeks
Safety
Reduction in nasal congestion subscore
Time Frame: 2 weeks
Effectiveness
Secondary Outcomes
- Adverse events(2 weeks)
- Total Nasal Symptom Score (TNSS)(2 weeks)
Study Sites (1)
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