Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up

Not Applicable

Completed

• Conditions: Chronic Sinusitis
• Interventions: Device: Balloon Sinus Dilation; Procedure: Functional Endoscopic Sinus Surgery

• Registration Number: NCT01525849
• Lead Sponsor: Entellus Medical, Inc.

Brief Summary

The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.

Detailed Description

This is a postmarket, multicenter, prospective, randomized clinical trial conducted at up to 15 US clinical sites comparing the efficacy of balloon sinus dilation with traditional endoscopic sinus surgery. The primary hypotheses were to demonstrate that: 1) long-term change in sinus symptoms after balloon dilation is not worse (non-inferior) than after FESS, and 2) balloon dilation is superior to FESS for a reduction in the number of postoperative debridements per patient. A minimum of 36 participants per arm is required to test the primary hypotheses. All participants will be followed through a minimum of 12 months post treatment.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-03
• Primary Completion: 2014-02
• Study Completion: 2014-05
• Results First Submitted: 2016-11-01
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-04
• Last Update Submitted: 2017-01-04
• Results First Posted: 2017-02-24
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• 18 years or older
• maxillary sinus disease
• chronic sinusitis

Exclusion Criteria

• fungal disease
• Samter's triad
• hemophilia
• prior sinus surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balloon Sinus Dilation	Balloon Sinus Dilation	XprESS Multi-Sinus Dilation Balloon, FinESS Sinus Treatment
Functional Endoscopic Sinus Surgery	Functional Endoscopic Sinus Surgery	Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.

Primary Outcome Measures

Name	Time	Method
Sinus Symptom Improvement	Baseline and 1-year	Change from baseline in overall 20-item Sino-Nasal Outcome Test (SNOT-20) score. The SNOT-20 is a validated patient reported survey of 20 items related to sinonasal symptoms and severity assessed over the previous 2 weeks. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be). The individual item scores are averaged to provide and overall score that ranges from 0 (best) to 5 (worst).
Debridements	1-year	Number of postoperative debridements per participant

Secondary Outcome Measures

Name	Time	Method
Revision Rate	1-year	Number of participants requiring repeat sinus procedures
Recovery Time	6-months	Mean time (days) after procedure for participants to return to normal activities
Complication Rate	Duration of study (minimum of 12 months)	Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure

Trial Locations

Locations (1)

Entellus Medical; 🇺🇸 Plymouth, Minnesota, United States