Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Sinusitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XprESS Multi-Sinus Dilation Tool

Balloon sinus dilation

Group Type EXPERIMENTAL

XprESS Multi-Sinus Dilation Tool

Intervention Type DEVICE

Sinus balloon dilation

Interventions

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XprESS Multi-Sinus Dilation Tool

Sinus balloon dilation

Intervention Type DEVICE

Other Intervention Names

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Sinus balloon dilation

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No