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NCT01990820 · ClinicalTrials.gov registry record · NA
Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty
A NA study, sponsored by Endeavor Health.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT01990820 is a NA study that has completed, run by Endeavor Health. The registered enrollment target is 25 participants.
The verdict
NCT01990820, a NA study, has completed, sponsored by Endeavor Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
Chronic rhinosinusitis, a common diagnosis in children, remains a poorly understood disease. Adenoidectomy (surgery to take out the adenoid pads- infection fighting glands in the back of the throat) is performed since the adenoid pad may trap germs that enter a child's body and can get so swollen with bacteria that they become infected themselves. Functional endoscopic sinus surgery (FESS) and adenoidectomy are currently the most common surgeries performed on children with this disease. Another treatment is adenoidectomy and irrigation of the maxillary sinus without FESS. New technology has emerged using a balloon catheter to dilate (open) the sinus passage in addition to the adenoidectomy and irrigation. This study seeks to answer if children with chronic rhinosinusitis who undergo adenoidectomy with balloon dilation of the maxillary sinus passage and irrigation experience improved quality of life outcomes compared to children with chronic rhinosinusitis who undergo an adenoidectomy with maxillary sinus irrigation without dilation of the sinus passage.
Interventions
- DEVICE Acclarent Relieva Balloon Sinuplasty
- PROCEDURE Adenoidectomy + Maxillary Sinus Irrigation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2009-03 |
| Est. Completion | 2016-09-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01990820
The ClinicalTrials.gov registry entry for NCT01990820 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endeavor Health, which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Acclarent Relieva Balloon Sinuplasty is the first listed.
NCT01990820 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01990820 about?
NCT01990820 is a clinical study titled "Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty". Chronic rhinosinusitis, a common diagnosis in children, remains a poorly understood disease. Adenoidectomy (surgery to take out the adenoid pads- infection fighting glands in the back of the throat) is performed since the adenoid pad may trap germs that enter a child's body and can get so swollen wi...
What is the current status of trial NCT01990820?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2009-03. Estimated completion is 2016-09-29.
What interventions are being tested in trial NCT01990820?
The interventions under investigation include: Acclarent Relieva Balloon Sinuplasty (DEVICE), Adenoidectomy + Maxillary Sinus Irrigation (PROCEDURE).
Who is sponsoring clinical trial NCT01990820?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
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