Status:
COMPLETED
NuVent™ Revision Study
Lead Sponsor:
Medtronic Surgical Technologies
Conditions:
Chronic Rhinosinusitis
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT02284347
Start Date
December 1 2014
End Date
May 1 2015
Last Update
August 24 2016
Active Locations (1)
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1
Philadelphia, Pennsylvania, United States