CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
Electromagnetic Sinus Dilation System (NuVent™)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02284347
NCT02284347N/ACompleted
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NuVent™ Revision Study

Medtronic Surgical Technologies·interventional·Posted Nov 6, 2014·Updated Aug 24, 2016

In Brief

A clinical study evaluating Electromagnetic Sinus Dilation System (NuVent™) for Chronic Rhinosinusitis. Completed, enrolled 51 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Rhinosinusitis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 6, 2014
Enrollment StartDec 1, 2014
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.7 years ago

Interventions

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.