A prospective, single-arm, post approval pilot study.
This study is evaluating transnasal sinus balloon dilation without tissue removal to treat the maxillary sinuses in patients with sinusitis. The study will be assessing symptomatic improvement post procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Entellus Medical
Plymouth, Minnesota, United States
Synergy ENT Specialists
St Louis, Missouri, United States
SNOT-20 Score
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 total SNOT-20 score.
Time frame: Baseline and 6 months post procedure
Recovery Time
Patient-reported time from procedure to ability to return to normal daily activities.
Time frame: 1 week post procedure
Procedural Pain Scores
Procedure pain/discomfort on a scale of 0 (no pain) to 10 (severe pain) as reported by the participant.
Time frame: Immediately post procedure
Revision Rate
The number of participants who require revision sinus surgery during the study duration.
Time frame: 6 Months post procedure
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