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BREATHE Long-Term Follow-Up Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01319305
First Posted: March 21, 2011
Last Update Posted: June 28, 2011
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.
Information provided by:
Entellus Medical, Inc.
  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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01319305


Locations
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
ClinicalTrials.gov Identifier: NCT01319305     History of Changes
Other Study ID Numbers: 1743-001
First Submitted: March 14, 2011
First Posted: March 21, 2011
Last Update Posted: June 28, 2011
Last Verified: June 2011

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