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Home Usability of a Nasal Lavage System in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01129765
First Posted: May 25, 2010
Last Update Posted: August 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aardvark Medical Company
Results First Submitted: June 2, 2010  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Conditions: Nasal Congestion
Respiratory Tract Infection
Sinusitis
Allergic Rhinitis
Intervention: Device: Use of an automatic nasal irrigator/aspirator

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was performed in a pediatric ambulatory clinic in July and August of 2009. The clinical coordinator identified patients as they presented to the clinic if they met inclusion criteria and informed consent was obtained before patient entry.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Parents of Congested Children Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.

Participant Flow:   Overall Study
    Parents of Congested Children
STARTED   30 
COMPLETED   30 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Parents of Congested Children Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.

Baseline Measures
   Parents of Congested Children 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Participants]
 
<=18 years   30 
Between 18 and 65 years   0 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 0.75  (0.25) 
Gender 
[Units: Participants]
 
Female   17 
Male   13 
Region of Enrollment 
[Units: Participants]
 
United States   30 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device   [ Time Frame: Day one, immediately ]

2.  Secondary:   Number of Participants Who Experienced Ease of Use With the Device   [ Time Frame: Day one, immediately ]

3.  Secondary:   Number of Participants Who Found the Device to be Effective   [ Time Frame: Day one, immediately ]

4.  Secondary:   Number of Participants Who Identified the Device's User Manual as Easy to Understand   [ Time Frame: Day one, immediately ]

5.  Secondary:   Number of Patients Who Were Observed to Have an Adverse Event   [ Time Frame: Day one, immediately ]

6.  Secondary:   Number of Patients Experiencing a Physical Injury During Use   [ Time Frame: Day one, immediately ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mary Margaret Thorne
Organization: Advanced Pediatrics
phone: 703-938-5555
e-mail: mthorne@pop.powweb.com



Responsible Party: Richard Schwartz, MD, Advanced Pediatrics
ClinicalTrials.gov Identifier: NCT01129765     History of Changes
Other Study ID Numbers: AM-002
First Submitted: May 21, 2010
First Posted: May 25, 2010
Results First Submitted: June 2, 2010
Results First Posted: July 5, 2010
Last Update Posted: August 3, 2010