NuVent™ Revision Study

Study Overview
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Brief Summary
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This is a prospective, non-randomized, single-arm study designed to assess the safety and device performance of the NuVent navigation-guided balloon system for use in subjects with scarred, granulated, or previously surgically altered tissue (revision).

Conditions
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Chronic Rhinosinusitis

Intervention / Treatment
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* Device: Electromagnetic Sinus Dilation System (NuVent™)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years of age. Subject has chronic rhinosinusitis unresponsive to medical therapy and previous sinus surgery. Subject has sinus surgery planned on at least one of the frontal, sphenoid or maxillary sinus ostia. Subject has scarred, granulated or previously surgically altered tissue for which an image-guided balloon tool may be feasible, in the opinion of the Investigator. Subject is willing and able to comply with protocol requirements. Exclusion Criteria: Subject is pregnant or breastfeeding. Subject is not healthy enough to undergo endoscopic sinus surgery based on the opinion of the Investigator. Subject has sinonasal tumors. Subject is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint. Subject lacks capacity to consent to participation in this research himself/herself.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NuVent™<br>Revision patients treated with NuVent™ | Device: Electromagnetic Sinus Dilation System (NuVent™)<br>* NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium | Two-fold endpoint: Investigator-assessment regarding the number of sinuses that were easily navigated to the desired treatment location and easy dilation of the ostium | At time of surgery | 
| Device-related Adverse Event Point Estimate | The primary safety endpoint was the point estimate (and confidence interval) for all AEs that were directly attributable to the device or for which the cause could not be determined and that met the definition of designated primary safety endpoint AEs as defined in the protocol. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Safety Profile as Measured by the Overall Adverse Event Rate | Overall adverse event rate | 2 weeks |