Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

This study has been completed.
Sponsor:
Information provided by:
Carbylan BioSurgery, Inc.
ClinicalTrials.gov Identifier:
NCT00554190
First received: November 2, 2007
Last updated: April 22, 2009
Last verified: March 2009
Results First Received: November 14, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Ethmoid Sinusitis
Rhinosinusitis
Interventions: Device: AdvaCoat sinus gel
Device: Merogel Injectable

  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
First subject treatment: May 2007. Last subject treatment: December 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 29 subjects were treated. Nineteen subjects were followed through 60 days post-treatment.

Reporting Groups
  Description
AdvaCoat and Merogel AdvaCoat compared to Merogel Injectable. Subjects were randomized to receive AdvaCoat applied to the right or left middle meatus tissues and Merogel applied to the middle meatus tissues on the opposite side.

Participant Flow:   Overall Study
    AdvaCoat and Merogel  
STARTED     29 [1]
COMPLETED     19 [2]
NOT COMPLETED     10  
Termination forms not completed                 10  
[1] 29 subjects treated.
[2] 10 subjects did not complete the Termination Study Forms



  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
AdvaCoat and Merogel Injectable AdvaCoat compared with Merogel Injectable

Baseline Measures
    AdvaCoat and Merogel Injectable  
Number of Participants  
[units: participants]
  29  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     29  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  42  ± 14.5  
Gender  
[units: participants]
 
Female     14  
Male     15  
Region of Enrollment  
[units: participants]
 
United States     29  



  Outcome Measures
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1.  Primary:   Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale   [ Time Frame: Post-operative through 60 days ]

2.  Primary:   Number of Participants With Solicited and Recorded Adverse Events   [ Time Frame: Post-operative through 60 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 NOT 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.


Results Point of Contact:  
Name/Title: Marcee Maroney, VP Clinical Affairs
Organization: Carbylan BioSurgery Inc.
phone: 650 855 6774
e-mail: mmaroney@carbylan.com


No publications provided


Responsible Party: Marcee Maroney, V.P. Marketing and Clinical Affairs, Carbylan BioSurgery, Inc.
ClinicalTrials.gov Identifier: NCT00554190     History of Changes
Other Study ID Numbers: ACOT 1.0
Study First Received: November 2, 2007
Results First Received: November 14, 2008
Last Updated: April 22, 2009
Health Authority: United States: Institutional Review Board