Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

Entellus Medical

Status: Completed

Conditions: Sinusitis

Treatments: Device: XprESS Multi-Sinus Dilation Tool

Study type: Interventional

Funder types: Industry

Identifiers

NCT01612780

2233-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

XprESS Multi-Sinus Dilation Tool

Experimental group

Description:

Balloon sinus dilation

Treatment:

Device: XprESS Multi-Sinus Dilation Tool