BREATHE Long-Term Follow-Up Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01319305
Recruitment Status : Completed
First Posted : March 21, 2011
Last Update Posted : June 28, 2011
Information provided by:
Entellus Medical, Inc.

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

Condition or disease Intervention/treatment
Chronic Sinus Disease Device: FinESS Sinus Treatment

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BREATHE Long-Term Follow-Up Study
Study Start Date : April 2010
Actual Primary Completion Date : June 2011

Group/Cohort Intervention/treatment
BREATHE I participatants Device: FinESS Sinus Treatment
balloon sinuplasty

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01319305

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

Responsible Party: Robyn Schacherer, Principal CRA, Entellus Medical Identifier: NCT01319305     History of Changes
Other Study ID Numbers: 1743-001
First Posted: March 21, 2011    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases