Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)

This study has been completed.
Sponsor:
Information provided by:
Acclarent
ClinicalTrials.gov Identifier:
NCT00231062
First received: September 30, 2005
Last updated: June 10, 2011
Last verified: June 2011
Results First Received: April 29, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Sinusitis
Intervention: Device: Sinuplasty

  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
Recruited from 3/2005 to 12/2005 in physician practice

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Balloon Dilation of Sinus Ostia No text entered.

Participant Flow:   Overall Study
    Balloon Dilation of Sinus Ostia  
STARTED     115  
COMPLETED     109  
NOT COMPLETED     6  
Physician Decision                 6  



  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 of Sinus Ostia No text entered.

Baseline Measures
    Balloon Dilation of Sinus Ostia  
Number of Participants  
[units: participants]
  115  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     102  
>=65 years     13  
Age  
[units: years]
Mean ± Standard Deviation
  47.8  ± 12.59  
Gender  
[units: participants]
 
Female     74  
Male     41  
Region of Enrollment  
[units: participants]
 
United States     115  



  Outcome Measures
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1.  Primary:   Number of Sinuses With Patency of Sinus Ostium After Sinuplasty   [ Time Frame: 24 weeks ]

2.  Primary:   Number of Participants With Adverse Events Following Sinuplasty Procedure   [ Time Frame: 24 weeks ]

3.  Secondary:   Number of Participants Experiencing Relief of Sinus Symptoms   [ Time Frame: Week 24 ]


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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: Laura England, Manager-Clinical Affairs
Organization: Acclarent
phone: 650-687-4466
e-mail: lenglan1@its.jnj.com


No publications provided


Responsible Party: Laura England, Manager-Clinical Affairs, Acclarent, Inc.
ClinicalTrials.gov Identifier: NCT00231062     History of Changes
Other Study ID Numbers: CP-00313
Study First Received: September 30, 2005
Results First Received: April 29, 2011
Last Updated: June 10, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration