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OpenTrials
Completed

NCT Number: NCT01319305

BREATHE Long-Term Follow-Up Study

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

Completed

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Key information

Conditions

Chronic Sinus Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Cloud ENT

Saint Cloud, Minnesota, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

FinESS Sinus Treatment

Device

balloon sinuplasty

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Entellus Medical, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
First posted
Mar 21, 2011
Registry last updated
Jun 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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