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XprESS Registry Study

NCT01115309 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2020-10-27

Study results available
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Summary

This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).

Conditions

  • Sinusitis

Interventions

DEVICE

XprESS Balloon Device

Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).

Sponsors & Collaborators

  • Entellus Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeff Grebner · Entellus Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-12-31
Completion
2011-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01115309 on ClinicalTrials.gov