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NCT01525862 · ClinicalTrials.gov registry record · NA
XprESS Maxillary Balloon Dilation Study
A NA study of Chronic Rhinosinusitis (Diagnosis) and Chronic Sinusitis, sponsored by Entellus Medical.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
- 2
- Study locations
NCT01525862: Completed NA study of Chronic Rhinosinusitis (Diagnosis) and Chronic Sinusitis, sponsored by Entellus Medical.
NCT01525862 is a NA study of Chronic Rhinosinusitis (Diagnosis) and Chronic Sinusitis that has completed, run by Entellus Medical. The registered enrollment target is 21 participants, below the 88-participant average among 9 other Chronic Rhinosinusitis (Diagnosis) trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01525862, a NA study of Chronic Rhinosinusitis (Diagnosis) and Chronic Sinusitis, has completed, sponsored by Entellus Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
- 2
- Study locations
Study Summary
A prospective, single-arm, post approval pilot study.
Primary Outcome
The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the t
Conditions Studied
Interventions
- DEVICE Balloon sinus dilation
Study Locations (2)
Minnesota
- Entellus Medical - Plymouth
Missouri
- Synergy ENT Specialists - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-01 |
| Phase | NA |
What the finished NCT01525862 record still lists
NCT01525862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 88-participant average among 9 other Chronic Rhinosinusitis (Diagnosis) trials with a reported enrollment target (76% lower).
The record links to 2 conditions, with Chronic Rhinosinusitis (Diagnosis) appearing as the primary indexed condition, and to 1 intervention - of which Balloon sinus dilation is the first listed.
NCT01525862 reports a single indexed study location in Minnesota, Missouri.
Frequently Asked Questions
What is clinical trial NCT01525862 about?
NCT01525862 is a clinical study titled "XprESS Maxillary Balloon Dilation Study". A prospective, single-arm, post approval pilot study.
What is the current status of trial NCT01525862?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2011-12. Estimated completion is 2013-01.
What conditions does trial NCT01525862 study?
This clinical trial studies the following conditions: Chronic Rhinosinusitis (Diagnosis), Chronic Sinusitis.
What interventions are being tested in trial NCT01525862?
The interventions under investigation include: Balloon sinus dilation (DEVICE).
Who is sponsoring clinical trial NCT01525862?
This trial is sponsored by Entellus Medical, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01525862 being conducted?
This trial has 2 study locations across Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Rhinosinusitis (Diagnosis)
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 NCT01525862's enrollment target sits among peer trials
21 8th of 9 higher than 2 of 9 other Chronic Rhinosinusitis (Diagnosis) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Rhinosinusitis (Diagnosis) 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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