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BREATHE Long-Term Follow-Up Study

This study has been completed.
Information provided by:
Entellus Medical, Inc. Identifier:
First received: March 14, 2011
Last updated: June 27, 2011
Last verified: June 2011
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 ]
    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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who were treated with FinESS Sinus Treatment in the BREATHE I Study

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01319305

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

Responsible Party: Robyn Schacherer, Principal CRA, Entellus Medical Identifier: NCT01319305     History of Changes
Other Study ID Numbers: 1743-001
Study First Received: March 14, 2011
Last Updated: June 27, 2011

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases processed this record on August 18, 2017