Home Usability of a Nasal Lavage System in Children

Completed

Conditions studied: Nasal Congestion, Respiratory Tract Infection, Sinusitis, Allergic Rhinitis

In brief

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.

Key facts

Study ID

NCT01129765

Run by

Aardvark Medical Company

People needed

30

Starts

2009-07-01

Expected to finish

2009-08-01

Last updated by the study team

2010-08-03

Who can join

Age: any, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parents of children less than 6 years of age who were suffering from nasal congestion for which nasal suctioning and salt water irrigation/drops are prescribed.

You may not qualify if…

• Parents of children in marked respiratory distress or who maxillofacial malformations not conducive to nasal suctioning.
• Additionally, parents of children with recurrent nose bleeds, bleeding disorders or irritated peri-nasal skin were excluded.

Where it is running

• Advanced Pediatrics — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

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