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NCT01525849 · ClinicalTrials.gov registry record · NA
Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up
A NA study of Chronic Sinusitis, sponsored by Entellus Medical.
- Completed
- Registry status
- NA
- Development phase
- 151
- Enrollment target
- 1
- Study location
NCT01525849: Completed NA study of Chronic Sinusitis, sponsored by Entellus Medical.
NCT01525849 is a NA study of Chronic Sinusitis that has completed, run by Entellus Medical. The registered enrollment target is 151 participants, below the 179-participant average among 9 other Chronic Sinusitis trials with a reported enrollment target (16% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01525849, a NA study of Chronic Sinusitis, has completed, sponsored by Entellus Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 151 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.
Primary Outcome
Change from baseline in overall 20-item Sino-Nasal Outcome Test (SNOT-20) score. The SNOT-20 is a validated patient reported survey of 20 items related to sinonasal symptoms and severity assessed over the previous 2 weeks. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be). The individual item scores are averaged to provide and overall score that ranges from 0 (best) to 5 (worst).
Conditions Studied
Interventions
- DEVICE Balloon Sinus Dilation
- PROCEDURE Functional Endoscopic Sinus Surgery
Study Locations (1)
Minnesota
- Entellus Medical - Plymouth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-05 |
| Phase | NA |
What the finished NCT01525849 record still lists
NCT01525849 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 179-participant average among 9 other Chronic Sinusitis trials with a reported enrollment target (16% lower).
The record links to 1 condition, with Chronic Sinusitis appearing as the primary indexed condition, and to 2 interventions - of which Balloon Sinus Dilation is the first listed.
NCT01525849 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01525849 about?
NCT01525849 is a clinical study titled "Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up". The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.
What is the current status of trial NCT01525849?
This trial is currently completed. It is a NA study. The enrollment target is 151 participants. The study started on 2011-12. Estimated completion is 2014-05.
What conditions does trial NCT01525849 study?
This clinical trial studies the following conditions: Chronic Sinusitis.
What interventions are being tested in trial NCT01525849?
The interventions under investigation include: Balloon Sinus Dilation (DEVICE), Functional Endoscopic Sinus Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT01525849?
This trial is sponsored by Entellus Medical, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01525849 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Sinusitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01525849's enrollment target sits among peer trials
151 3rd of 9 higher than 7 of 9 other Chronic Sinusitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Sinusitis 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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