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BREATHE Long-Term Follow-Up Study

This study has been completed.
Sponsor:
Information provided by:
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01319305
First received: March 14, 2011
Last updated: June 27, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention
Chronic Sinus Disease
 Device: FinESS Sinus Treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BREATHE Long-Term Follow-Up Study

Further study details as provided by Entellus Medical, Inc.:

Primary Outcome Measures:
  • SNOT-20 scores [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
    Assess post-procedure outcomes defined as SNOT-20 scores and work productivity assessment questionnaires aproximately 24 months post-procedure


Estimated Enrollment: 70
Study Start Date: April 2010
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BREATHE I participatants Device: FinESS Sinus Treatment
balloon sinuplasty

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants who were treated with FinESS Sinus Treatment in the BREATHE I Study

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319305

Locations
United States, Minnesota
St. Cloud ENT
St. Cloud, Minnesota, United States
Sponsors and Collaborators
Entellus Medical, Inc.
  More Information

No publications provided

Responsible Party: Robyn Schacherer, Principal CRA, Entellus Medical
ClinicalTrials.gov Identifier: NCT01319305     History of Changes
Other Study ID Numbers: 1743-001
Study First Received: March 14, 2011
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013