Clinical Evaluation of the Ethmoid Sinus Spacer (SPACER)

This study has been completed.
Sponsor:
Information provided by:
Acclarent
ClinicalTrials.gov Identifier:
NCT01054703
First received: January 20, 2010
Last updated: June 10, 2011
Last verified: June 2011
Results First Received: February 8, 2010  
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: Sinusitis, Chronic Rhinosinusitis
Intervention: Device: Ethmoid Sinus Spacer

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Ethmoid Sinus Spacer Placement Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40

Participant Flow:   Overall Study
    Ethmoid Sinus Spacer Placement  
STARTED     14  
COMPLETED     14  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Ethmoid Sinus Spacer Placement Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40

Baseline Measures
    Ethmoid Sinus Spacer Placement  
Number of Participants  
[units: participants]
  14  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     14  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  50.1  ± 9.6  
Gender  
[units: participants]
 
Female     5  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     14  



  Outcome Measures

1.  Primary:   Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant   [ Time Frame: Procedural and 6 weeks post-implant ]

2.  Secondary:   Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures   [ Time Frame: 1 wk, 2wk, 4wk, 6wk ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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.


Results Point of Contact:  
Name/Title: Laura England, Manager-Clinical Research
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: NCT01054703     History of Changes
Other Study ID Numbers: CPR02082
Study First Received: January 20, 2010
Results First Received: February 8, 2010
Last Updated: June 10, 2011
Health Authority: United States: Institutional Review Board