NuVent™ Revision Study

Completed · Not applicable

Conditions studied: Chronic Rhinosinusitis

In brief

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).

Key facts

Study ID

NCT02284347

Run by

Medtronic Surgical Technologies

People needed

51

Starts

2014-12-01

Expected to finish

2015-05-01

Last updated by the study team

2016-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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