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Parents of congested children for Respiratory Infections

N/A
Waitlist Available
Led By Richard Schwartz, MD
Research Sponsored by Aardvark Medical Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day one, immediately
Awards & highlights

Study 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.

Eligible Conditions
  • Respiratory Infections
  • Sinus Infection
  • Allergy or Hay Fever
  • Stuffy Nose

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day one, immediately
This trial's timeline: 3 weeks for screening, Varies for treatment, and day one, immediately for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device
Secondary outcome measures
Number of Participants Who Experienced Ease of Use With the Device
Number of Participants Who Found the Device to be Effective
Number of Participants Who Identified the Device's User Manual as Easy to Understand
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Parents of congested childrenExperimental Treatment1 Intervention
Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Use of an automatic nasal irrigator/aspirator
2009
N/A
~30

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Who is running the clinical trial?

Aardvark Medical CompanyLead Sponsor
Richard Schwartz, MDPrincipal InvestigatorAdvanced Pediatrics
~2 spots leftby Jul 2025
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