CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Use of an automatic nasal irrigator/aspiratordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01129765
NCT01129765N/ACompleted
CompareCT.gov

Home Usability of a Nasal Lavage System in Children

Aardvark Medical Company·observational·Posted May 25, 2010·Updated Aug 3, 2010

In Brief

An observational study evaluating Use of an automatic nasal irrigator/aspirator for Nasal Congestion and 3 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This study evaluates labeling comprehension, ease of use and effectiveness of a new device for nasal and sinus irrigation and/or aspiration. The device is currently cleared for professional use and home use with a prescription. This is a usability study to demonstrate that this device is appropriate for home use.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsNasal Congestion, Respiratory Tract Infection, Sinusitis, Allergic Rhinitis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 25, 2010
Enrollment StartJul 1, 2009
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.1 years ago

Interventions

Use of an automatic nasal irrigator/aspiratordevice

After reading the device's user manual, parents were asked to use it on their congested children to their satisfaction. During this time, a clinical observer recorded predetermined steps that needed to be performed for success as well as presence of any adverse events.