Status:

COMPLETED

Healthcare Utilization and Outcomes of FinESS Treatment in the Office

Lead Sponsor:

Entellus Medical, Inc.

Conditions:

Rhinosinusitis

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.

Detailed Description

A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office. Also to demonstr...

Eligibility Criteria

Inclusion

  • 18 years or older
  • Male or female subjects
  • Diagnosis of rhinosinusitis (CT radiographic evidence and medical evaluation)
  • Willing to comply with protocol requirements
  • Able to provide consent

Exclusion

  • Hemophilia
  • Cystic fibrosis
  • Ciliary dysfunction
  • Severe septal deviation causing obstruction of the ostiomeatal unit
  • Pregnant females

Key Trial Info

Start Date :

September 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2012

Estimated Enrollment :

74 Patients enrolled

Trial Details

Trial ID

NCT00986830

Start Date

September 1 2009

End Date

September 1 2012

Last Update

October 27 2020

Active Locations (13)

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Page 1 of 4 (13 locations)

1

Central California ENT

Fresno, California, United States, 93720

2

South Denver ENT and Allergy

Denver, Colorado, United States, 80120

3

ENT and Allergy Associates

Trumbull, Connecticut, United States, 06611

4

NorthShore University

Evanston, Illinois, United States, 60201