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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: Completed NA study, sponsored by Endeavor Health.
NCT01990820 is a NA study that has completed, run by Endeavor Health. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The care giver for each subject will be asked to complete SN-5 Pediatric sinonasal symptom survey (SN-5) at baseline (prior to surgery) and 6 and 12 months post surgery. The SN-5 is a health-related qualify of life (QOL) questionnaire which consists of 5 questions about sinus problems (sinus infection, nasal obstruction, allergy symptoms, emotional distress, activity limitations) each of which is scored by the caregiver on a 7 point response scale. The 5 responses are then averaged into an SN-5
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 |
What the finished NCT01990820 record still lists
NCT01990820 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Acclarent Relieva Balloon Sinuplasty is the first listed.
NCT01990820 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01990820's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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