Trial Outcomes & Findings for NuVent™ Revision Study (NCT NCT02284347)

NCT ID: NCT02284347

Last Updated: 2016-08-24

Results Overview

Two-fold endpoint: Investigator-assessment regarding the number of sinuses that were easily navigated to the desired treatment location and easy dilation of the ostium

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 51 participants
• Primary outcome timeframe: At time of surgery
• Results posted on: 2016-08-24

Participant Flow

Participant milestones

Measure	NuVent™ Revision patients treated with NuVent™ Electromagnetic Sinus Dilation System (NuVent™): 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.
Overall Study STARTED	51
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	NuVent™ Revision patients treated with NuVent™ Electromagnetic Sinus Dilation System (NuVent™): 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.
Overall Study Lost to Follow-up	2
Overall Study Withdrawn prior to treatment	1

Baseline Characteristics

NuVent™ Revision Study

Baseline characteristics by cohort

Measure	NuVent™ n=51 Participants Revision patients treated with NuVent™ Electromagnetic Sinus Dilation System (NuVent™): 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.
Age, Continuous	57.6 years STANDARD_DEVIATION 14.02 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants

PRIMARY outcome

Timeframe: At time of surgery

Population: All patients that completed the study

Two-fold endpoint: Investigator-assessment regarding the number of sinuses that were easily navigated to the desired treatment location and easy dilation of the ostium

Outcome measures

Measure

NuVent™ n=48 Participants Revision patients treated with NuVent™ Electromagnetic Sinus Dilation System (NuVent™): 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.

Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium

121 Number of sinuses

PRIMARY outcome

Timeframe: 2 weeks

Population: Participants

The primary safety endpoint was the point estimate (and confidence interval) for all AEs that were directly attributable to the device or for which the cause could not be determined and that met the definition of designated primary safety endpoint AEs as defined in the protocol.

Outcome measures

Measure

NuVent™ n=51 Participants Revision patients treated with NuVent™ Electromagnetic Sinus Dilation System (NuVent™): 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.

Device-related Adverse Event Point Estimate

0 Adverse Events Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 2 weeks

Overall adverse event rate

Outcome measures

Measure

NuVent™ n=51 Participants Revision patients treated with NuVent™ Electromagnetic Sinus Dilation System (NuVent™): 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.

Device Safety Profile as Measured by the Overall Adverse Event Rate

18 Percentage of participants with an AE

Adverse Events

NuVent™

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Trials

Medtronic Xomed

Phone: 904-296-9600

Email: dl.nuventstudy@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60