BREATHE Long-Term Follow-Up Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01319305

Enrollment

Registered

2011-03-21

Start date

2010-04-30

Completion date

Unknown

Last updated

2011-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Sinus Disease

Brief summary

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

Interventions

DEVICEFinESS Sinus Treatment

balloon sinuplasty

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
SNOT-20 scores	approximately 24 months	Assess post-procedure outcomes defined as SNOT-20 scores and work productivity assessment questionnaires aproximately 24 months post-procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026