BREATHE Long-Term Follow-Up Study

Chronic Sinus Disease Clinical Trial

Official title:

BREATHE Long-Term Follow-Up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319305
• Other study ID #: 1743-001
• Status: Completed
• Phase: N/A
• First received: March 14, 2011
• Last updated: June 27, 2011
• Start date: April 2010

Study information

• Verified date: June 2011
• Source: Entellus Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participated in BREATHE I study

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Sinus Disease

Intervention

Device:
• FinESS Sinus Treatment
balloon sinuplasty

Locations

Country	Name	City	State
United States	St. Cloud ENT	St. Cloud	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Entellus Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SNOT-20 scores	Assess post-procedure outcomes defined as SNOT-20 scores and work productivity assessment questionnaires aproximately 24 months post-procedure	approximately 24 months	No