Balloon REmodeling Antrostomy THErapy Study (BREATHE I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00645762
First received: March 20, 2008
Last updated: June 20, 2013
Last verified: June 2013
Results First Received: March 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sinusitis
Interventions: Device: RS-Series Rhinosinusitis Treatment System
Device: FinESS Balloon

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrolled patients with chronic rhinosinusitis (CRS) from Ear, Nose Throat (ENT) physician practices.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients had transantral balloon dilation of the maxillary sinus ostium and ethmoid infundibulum with the FinESS Sinus System.

Reporting Groups
  Description
FinESS Sisnus System Balloon Dilation Transantral balloon dilation ofthe maxillary sinuses with the FinESS Sinus System.

Participant Flow:   Overall Study
    FinESS Sisnus System Balloon Dilation  
STARTED     71  
COMPLETED     67  
NOT COMPLETED     4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Balloon Dilation No text entered.

Baseline Measures
    Balloon Dilation  
Number of Participants  
[units: participants]
  71  
Age  
[units: years]
Mean ± Standard Deviation
  47.3  ± 13.7  
Gender  
[units: participants]
 
Female     45  
Male     26  
Region of Enrollment  
[units: participants]
 
United States     71  



  Outcome Measures
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1.  Primary:   Incidences of Device-related or Procedure-related Complications   [ Time Frame: Through 12 months post-procedure ]

2.  Primary:   Patency of the Treated Area as Verified by CT Scan   [ Time Frame: Post-treatment at 3 months ]

3.  Primary:   Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement   [ Time Frame: Post-treatment through 12 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Entellus Medical
Organization: Entellus Medical
phone: 763-463-1599


No publications provided by Entellus Medical, Inc.

Publications automatically indexed to this study:

Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT00645762     History of Changes
Other Study ID Numbers: 1156-001
Study First Received: March 20, 2008
Results First Received: March 15, 2013
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board