Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

Entellus Medical, Inc.82 enrolled

Overview

The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.

This is a prospective, non-randomized, single arm, post-approval study conducted under a common protocol designed to evaluate outcomes following trans-nasal balloon dilation of the maxillary sinus outflow tract with or without concurrent balloon dilation of the frontal or sphenoid sinuses and without any concomitant conventional sinus surgery (ie, uncinectomy, complete or partial ethmoidectomy).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sinusitis

Interventions

XprESS Multi-Sinus Dilation ToolDEVICE

Sinus balloon dilation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Be at least age 18 years old or older. 2. Be a candidate for transnasal balloon dilation of the maxillary sinus(es) with or without balloon dilation of the frontal or sphenoid sinus(es) using XprESS consistent with the device's Indication for Use. 3. Have a sinus CT scan within 12 months of the procedure date. 4. Be able and willing to provide consent. 5. Be willing to comply with the protocol requirements. Exclusion Criteria: 1. Have any prior maxillary sinus surgery (eg, antrostomy, uncinectomy). 2. Require any concomitant endoscopic sinus surgery (ESS) or nasal surgery (exception: turbinate reduction) at the time of the study procedure. 3. Have any nasal surgery (eg, septoplasty) or nonmaxillary sinus surgery (eg, frontal sinusotomy, sphenoidotomy, full/partial ethmoidectomy) performed within 3 months prior to enrollment. 4. Have presence of features consistent with sinus fungal disease. 5. Be allergic to nickel or barium sulfate. 6. Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.

Locations (1)

Entellus Medical

Plymouth, Minnesota, United States

Outcomes

Primary Outcomes

Change in 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 1-year post procedure

Secondary Outcomes

Revision Sinus Surgery

The number of participants who require revision sinus surgery to address continuing sinus symptoms.

Time frame: 1-year post procedure

Number of Participants With Serious Device and/or Procedure-related Adverse Events

Serious adverse events that are considered to be possibly, probably, or definitely related to the balloon device and/or dilation procedure.

Time frame: Through 1-year post procedure follow-up

Data from ClinicalTrials.gov

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