Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

Not Applicable

Completed

• Conditions: Sinusitis
• Interventions: Device: XprESS Multi-Sinus Dilation Tool

• Registration Number: NCT01612780
• Lead Sponsor: Entellus Medical, Inc.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-06
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2020-09-29
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-21
• Last Update Submitted: 2020-10-21
• Results First Posted: 2020-10-22
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
XprESS Multi-Sinus Dilation Tool	XprESS Multi-Sinus Dilation Tool	Balloon sinus dilation

Primary Outcome Measures

Name	Time	Method
Change in SNOT-20 Score	Baseline and 1-year 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
Number of Participants With Serious Device and/or Procedure-related Adverse Events	Through 1-year post procedure follow-up	Serious adverse events that are considered to be possibly, probably, or definitely related to the balloon device and/or dilation procedure.
Revision Sinus Surgery	1-year post procedure	The number of participants who require revision sinus surgery to address continuing sinus symptoms.

Trial Locations

Locations (1)

Entellus Medical; 🇺🇸 Plymouth, Minnesota, United States