NuVent™ Revision Study

NCT02284347 | Completed Results DMC

• 1 other identifier: TD-09330
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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, or previously surgically altered tissue (revision).

Conditions

Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (2)

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

  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

  At time of surgery

• Device-related Adverse Event Point Estimate

  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.

  2 weeks

Secondary Outcomes (1)

• Device Safety Profile as Measured by the Overall Adverse Event Rate

  2 weeks

Study Arms (1)

NuVent™

EXPERIMENTAL

Revision patients treated with NuVent™

Device: Electromagnetic Sinus Dilation System (NuVent™)

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.

NuVent™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Surgical Technologies: lead

Study Sites (1)

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Medtronic Xomed

dl.nuventstudy@medtronic.com

904-296-9600

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: November 6, 2014
• Study Start: December 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 24, 2016
• Results First Posted: August 24, 2016

Record last verified: 2016-07

Locations

US (1)