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

Entellus Medical

Status: Completed

Conditions: Chronic Sinusitis

Treatments: Device: Balloon Sinus Dilation; Procedure: Functional Endoscopic Sinus Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT01525849

1984-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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151 participants in 2 patient groups

Balloon Sinus Dilation

Active Comparator group

Description:

XprESS Multi-Sinus Dilation Balloon, FinESS Sinus Treatment

Treatment:

Device: Balloon Sinus Dilation

Functional Endoscopic Sinus Surgery

Active Comparator group

Description:

Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.

Treatment:

Procedure: Functional Endoscopic Sinus Surgery