N/A
N=51
NuVent™ Revision Study
Chronic Rhinosinusitis
Bottom Line
View on ClinicalTrials.gov: NCT02284347 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium — 121 Number of sinuses
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electromagnetic Sinus Dilation System (NuVent™) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Surgical Technologies
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium |
121 | — |
| PRIMARY Device-related Adverse Event Point Estimate |
— | — |
| SECONDARY Device Safety Profile as Measured by the Overall Adverse Event Rate |
18 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02284347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.