BREATHE Long-Term Follow-Up Study

Completed

• Conditions: Chronic Sinus Disease
• Interventions: Device: FinESS Sinus Treatment

• Registration Number: NCT01319305
• Lead Sponsor: Entellus Medical, Inc.

Brief Summary

This is a long-term follow-up of patients that participated in the BREATHE I study.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-18
• Study First Posted: 2011-03-21
• Status Verified: 2011-06
• Primary Completion: 2011-06
• Last Update Submitted: 2011-06-27
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Participated in BREATHE I study
• Willing to sign consent and participate in long-term follow-up study

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BREATHE I participatants	FinESS Sinus Treatment	-

Primary Outcome Measures

Name	Time	Method
SNOT-20 scores	approximately 24 months	Assess post-procedure outcomes defined as SNOT-20 scores and work productivity assessment questionnaires aproximately 24 months post-procedure

Trial Locations

Locations (1)

St. Cloud ENT; 🇺🇸 St. Cloud, Minnesota, United States