NuVent™ Revision Study

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Rhinosinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electromagnetic Sinus Dilation System (NuVent™)

Device

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.

Primary outcomes

Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium

Time frame: 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

Time frame: 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 outcomes

Device Safety Profile as Measured by the Overall Adverse Event Rate

Time frame: 2 weeks

Overall adverse event rate

Sponsors and collaborators

Lead sponsor

Medtronic Surgical Technologies

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Nov 6, 2014
Registry last updated: Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed