NuVent™ Revision Study

Medtronic

Status: Completed

Conditions: Chronic Rhinosinusitis

Treatments: Device: Electromagnetic Sinus Dilation System (NuVent™)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02284347

TD-09330

Details and patient eligibility

About

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).

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

NuVent™

Experimental group

Description:

Revision patients treated with NuVent™

Treatment:

Device: Electromagnetic Sinus Dilation System (NuVent™)