NuVent™ Revision Study

Not Applicable

Completed

• Conditions: Chronic Rhinosinusitis
• Interventions: Device: Electromagnetic Sinus Dilation System (NuVent™)

• Registration Number: NCT02284347
• Lead Sponsor: Medtronic Surgical Technologies

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-06
• Study Start: 2014-12
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-03-08
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-12
• Last Update Submitted: 2016-07-12
• Results First Posted: 2016-08-24
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1. Subject is at least 18 years of age.
2. Subject has chronic rhinosinusitis unresponsive to medical therapy and previous sinus surgery.
3. Subject has sinus surgery planned on at least one of the frontal, sphenoid or maxillary sinus ostia.
4. 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.
5. Subject is willing and able to comply with protocol requirements.

Exclusion Criteria

1. Subject is pregnant or breastfeeding.
2. Subject is not healthy enough to undergo endoscopic sinus surgery based on the opinion of the Investigator.
3. Subject has sinonasal tumors.
4. 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.
5. Subject lacks capacity to consent to participation in this research himself/herself.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NuVent™	Electromagnetic Sinus Dilation System (NuVent™)	Revision patients treated with NuVent™

Primary Outcome Measures

Name	Time	Method
Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium	At time of surgery	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
Device-related Adverse Event Point Estimate	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Device Safety Profile as Measured by the Overall Adverse Event Rate	2 weeks	Overall adverse event rate