Home Usability of a Nasal Lavage System in Children
This study has been completed.
Sponsor:
Aardvark Medical Company
Information provided by:
Aardvark Medical Company
ClinicalTrials.gov Identifier:
NCT01129765
First received: May 21, 2010
Last updated: July 27, 2010
Last verified: July 2010
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Results First Received: 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
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 |
|---|
| 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. |
Participant Flow: Overall Study
| Parents of Congested Children | |
|---|---|
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
Baseline Characteristics
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 | |
|---|---|
|
Number of Participants
[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
| 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 ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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. |
Limitations and Caveats
| 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 |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Mary Margaret Thorne
Organization: Advanced Pediatrics
phone: 703-938-5555
e-mail: mthorne@pop.powweb.com
Organization: Advanced Pediatrics
phone: 703-938-5555
e-mail: mthorne@pop.powweb.com
No publications provided
| Responsible Party: | Richard Schwartz, MD, Advanced Pediatrics |
| ClinicalTrials.gov Identifier: | NCT01129765 History of Changes |
| Other Study ID Numbers: | AM-002 |
| Study First Received: | May 21, 2010 |
| Results First Received: | June 2, 2010 |
| Last Updated: | July 27, 2010 |
| Health Authority: | United States: Institutional Review Board |