BREATHE Long-Term Follow-Up Study
1 other identifier
observational
70
1 country
1
Brief Summary
This is a long-term follow-up of patients that participated in the BREATHE I study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 14, 2011
CompletedFirst Posted
Study publicly available on registry
March 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedJune 28, 2011
June 1, 2011
1.2 years
March 14, 2011
June 27, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
BREATHE I participatants
Interventions
Eligibility Criteria
Participants who were treated with FinESS Sinus Treatment in the BREATHE I Study
You may qualify if:
- Participated in BREATHE I study
- Willing to sign consent and participate in long-term follow-up study
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Cloud ENT
Saint Cloud, Minnesota, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 14, 2011
First Posted
March 21, 2011
Study Start
April 1, 2010
Primary Completion
June 1, 2011
Last Updated
June 28, 2011
Record last verified: 2011-06