XprESS Maxillary Balloon Dilation Study

Not Applicable

Completed

Conditions: Chronic Sinusitis
Chronic Rhinosinusitis (Diagnosis)

Interventions: Device: Balloon sinus dilation

Registration Number: NCT01525862

Lead Sponsor: Entellus Medical, Inc.

Brief Summary: A prospective, single-arm, post approval pilot study.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

Inclusion Criteria

Be at least 18 years of age.
Must have uncomplicated sinusitis of the maxillary sinuses with or without anterior ethmoid disease.
Meet EITHER the Anthem Coverage Guideline OR BlueCross BlueShield of North Carolina Corporate Medical Policy for medically necessary functional endoscopic sinus surgery (FESS) to treat uncomplicated sinusitis.
Have a CT scan within 6 months prior to enrollment.
Be mentally and physically capable (as per physician discretion) to participate in the investigation.
Be willing and able to sign the study-specific informed consent prior to any study-related procedures.
Be willing and able to undergo balloon dilation in the clinic setting.

Exclusion Criteria

Have evidence of posterior ethmoid, sphenoid or frontal sinus (excludes presence of mucous retention cysts) disease requiring endoscopic sinus surgery or balloon dilatation.
Have presence of features consistent with sinus fungal disease.
Have evidence of gross polypoid disease within any of the sinuses or within the infundibulum.
Require concurrent nasal surgery (eg, septoplasty, turbinate reduction, etc).
Have previous sinus surgery (eg, sinus surgery or balloon sinuplasty).
Have nasal surgery (eg, septoplasty, turbinate reduction) performed within 3 months prior to enrollment.
Have any anatomical anomaly (ie, severe septal deviation) preventing transnasal access to the maxillary sinus outflow tract.
Have a history of primary ciliary dysfunction.
Have hemophilia.
Be currently undergoing, or have undergone in the past 6 months, chemotherapy for cancer or radiation therapy in the head or neck region.
Have a history of cystic fibrosis.
Have Sampter's Triad (ie, defined as having all 3 of the following: aspirin sensitivity, asthma, and sinonasal polyposis).
Have known sinonasal tumors or obstructive lesions.
Be pregnant at the time of enrollment.
Be unable to stop anticoagulant medication (eg, warfarin) until the International Normalized Ratio (INR) is below 1.5.
Be unable to stop antiplatelet (eg, clopidogrel, aspirin, etc.) for at least 7 days prior to study procedure.
Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Balloon sinus dilation	Balloon sinus dilation	Balloon dilation of the maxillary sinus using a transnasal approach.

Primary Outcome Measures

Name	Time	Method
SNOT-20 Score	Baseline and 6 months post procedure	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.

Secondary Outcome Measures

Name	Time	Method
Revision Rate	6 Months post procedure	The number of participants who require revision sinus surgery during the study duration.
Recovery Time	1 week post procedure	Patient-reported time from procedure to ability to return to normal daily activities.
Procedural Pain Scores	Immediately post procedure	Procedure pain/discomfort on a scale of 0 (no pain) to 10 (severe pain) as reported by the participant.