Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-03-15 @ 6:50 AM
Study NCT ID:
NCT03906968
Status:
COMPLETED
Last Update Posted:
2021-04-22
First Post:
2019-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Safety and Efficacy of a SinuSonic Intervention
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
SinuSonic Study for Adults With Nasal Congestion
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to test the safety and effectiveness of the SinuSonic device on adults with moderate to severe nasal congestion. SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. This device is held over the nose for 3 minutes. This study will use patient responses to measure how effective SinuSonic devices are in treating these moderate to severe congestion in adults. The study will consist of 40 subjects at the Medical University of South Carolina and will take place over the course of 4 to 6 weeks starting with a baseline assessment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: