A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis (ADVANCE II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intersect ENT
ClinicalTrials.gov Identifier:
NCT01253577
First received: December 2, 2010
Last updated: May 26, 2015
Last verified: May 2015
Results First Received: December 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Sinusitis
Interventions: Device: Sinus Stent with drug coating
Device: Non Coated Sinus Stent

  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
Patients were recruited in the United States between December 2009 and July 2010 from eleven otolaryngology-head and neck surgery centers by 31 surgeons representing both academic and private practices.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Sinus randomization was performed at the end of successful endoscopic sinus surgery.

Reporting Groups
  Description
Sinus Stent Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.

Participant Flow:   Overall Study
    Sinus Stent  
STARTED     105  
COMPLETED     102  
NOT COMPLETED     3  
Lost to Follow-up                 3  



  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.
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Reporting Groups
  Description
Sinus Stent Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.

Baseline Measures
    Sinus Stent  
Number of Participants  
[units: participants]
  105  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     95  
>=65 years     10  
Age  
[units: years]
Mean (Standard Deviation)
  46.5  (12.9)  
Gender  
[units: participants]
 
Female     45  
Male     60  
Region of Enrollment  
[units: participants]
 
United States     105  



  Outcome Measures
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1.  Primary:   Percentage of Sinuses Requiring Post-operative Intervention   [ Time Frame: 30-days ]

2.  Primary:   Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure   [ Time Frame: 90 days ]

3.  Secondary:   Percentage of Sinuses That Developed Frank Polyposis   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: James Stambaugh, Vice President Clinical Affairs
Organization: Intersect ENT
phone: 650-641-2103
e-mail: jstambaugh@intersectent.com


Publications of Results:

Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT01253577     History of Changes
Other Study ID Numbers: P500-1009
Study First Received: December 2, 2010
Results First Received: December 11, 2012
Last Updated: May 26, 2015
Health Authority: United States: Institutional Review Board