MedTrace Logo

Home Usability of a Nasal Lavage System in Children

NCT01129765 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2010-08-03

Study results available
· View outcomes & findings →

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.

Conditions

  • Nasal Congestion
  • Respiratory Tract Infection
  • Sinusitis
  • Allergic Rhinitis

Interventions

DEVICE

Use of an automatic nasal irrigator/aspirator

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.

Sponsors & Collaborators

  • Aardvark Medical Company

    lead INDUSTRY

Principal Investigators

  • Richard Schwartz, MD · Advanced Pediatrics

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01129765 on ClinicalTrials.gov