Chronic Sinus DiseaseNCT01319305
BREATHE Long-Term Follow-Up Study
An observational study of Chronic Sinus Disease, run by Entellus Medical, Inc. at 1 site in United States.
Trial summary
This is a long-term follow-up of patients that participated in the BREATHE I study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinus Disease
- What is being tested?
- FinESS Sinus Treatment
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who were treated with FinESS Sinus Treatment in the BREATHE I Study
Who may be able to join
- Participated in BREATHE I study
- Willing to sign consent and participate in long-term follow-up study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This is a long-term follow-up of patients that participated in the BREATHE I study.
- Conditions
- Chronic Sinus Disease
- Being tested
- FinESS Sinus Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinESS Sinus TreatmentDevice
balloon sinuplasty
| Study group | Role | What they receive |
|---|---|---|
| BREATHE I participatants | Not described Receives: Device: FinESS Sinus Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNOT-20 scores
Assess post-procedure outcomes defined as SNOT-20 scores and work productivity assessment questionnaires aproximately 24 months post-procedure
Measured: approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startApr 2010
- Primary completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Sinus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Entellus Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319305
- Sponsor's protocol ID
- 1743-001
- Status last verified
- Jun 2011
- First submitted
- 14 Mar 2011
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BREATHE Long-Term Follow-Up Study
- ClinicalTrials.gov ID
- NCT01319305
- Acronym / sponsor ID
- 1743-001
- Conditions
- Chronic Sinus Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Entellus Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- First posted
- 21 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a long-term follow-up of patients that participated in the BREATHE I study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BREATHE I participatants | – | Device: FinESS Sinus Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who were treated with FinESS Sinus Treatment in the BREATHE I Study
Key inclusion criteria (2 listed)
- Participated in BREATHE I study
- Willing to sign consent and participate in long-term follow-up study
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinESS Sinus Treatmentballoon sinuplasty | Device | BREATHE I participatants |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Sinus Disease, run by Entellus Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNOT-20 scores (time frame: approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.