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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
  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
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 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 November 27, 2014