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Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

This study has been completed.
Sponsor:
Information provided by:
Carbylan Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00554190
First received: November 2, 2007
Last updated: April 22, 2009
Last verified: March 2009

November 2, 2007
April 22, 2009
May 2007
December 2007   (final data collection date for primary outcome measure)
  • Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale [ Time Frame: Post-operative through 60 days ] [ Designated as safety issue: No ]
  • Number of Participants With Solicited and Recorded Adverse Events [ Time Frame: Post-operative through 60 days ] [ Designated as safety issue: No ]
Reduction of postoperative synechia (adhesion)formation [ Time Frame: Post-operative through 60 days ]
Complete list of historical versions of study NCT00554190 on ClinicalTrials.gov Archive Site
Not Provided
Subjective assessment of sinonasal symptoms post-operatively. [ Time Frame: Post-operative through 60 days ]
Not Provided
Not Provided
 
Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel
A Prospective, Multi-Center, Randomized, Controlled, Subject-Blinded Study to Evaluate the Safety and Effectiveness of AdvaCoat Sinus Gel Following Endoscopic Ethmoid Sinus Surgery

The purpose of this study is to evaluate the safety and effectiveness of AdvaCoat® sinus gel, a nasal/sinus dressing, for adhesion prevention following endoscopic ethmoid sinus surgery. 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.

Chronic rhinosinusitis is a very common condition, affecting 35 million Americans each year. All paranasal sinuses need ventilation to prevent infection and inflammation. Sinus ventilation occurs through the ostia into the nose. When rhinosinusitis occurs, the mucous membranes of the sinuses become swollen, resulting in ostia closure. Functional endoscopic sinus surgery (FESS) is a minimally invasive surgical procedure that opens the sinus ostia.

The most common unwanted side effect of the FESS procedure is the formation of adhesions (fibrous bands) in the area of surgery. These bands (adhesions) can prevent proper ventilation and drainage from the paranasal sinuses.

Various hyaluronan based biomaterials are now available and in common use to provide a post-surgical nasal dressing which is absorbable, can prevent adhesion formation, and eliminate the pain and tissue abrasion caused by removal of non-absorbable nasal packing.

AdvaCoat is a bioresorbable hyaluronan gel that conforms to mucosal surfaces and provides a post-surgical nasal dressing to prevent adhesion formation as tissues heal.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Ethmoid Sinusitis
  • Rhinosinusitis
  • Device: AdvaCoat sinus gel
    A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body
  • Device: Merogel Injectable
    Bioresorbable hyaluronic acid product
    Other Name: Merogel
  • Experimental: 1
    AdvaCoat compared to Merogel Injectable Bioresorbable Nasal Dressing
    Intervention: Device: AdvaCoat sinus gel
  • Active Comparator: 2
    Merogel Injectable Bioresorbable Nasal Dressing compared to AdvaCoat
    Intervention: Device: Merogel Injectable
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients who:

  1. Have bilateral chronic rhinosinusitis confirmed by physical exam, clinical history, and prior radiography
  2. Have bilateral ethmoid sinus disease
  3. Are scheduled for bilateral anterior or total ethmoidectomy

Exclusion Criteria:

  1. Unilateral ethmoid sinus disease
  2. Partial resection of middle turbinates, unilateral or bilateral
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00554190
ACOT 1.0
No
Marcee Maroney, V.P. Marketing and Clinical Affairs, Carbylan BioSurgery, Inc.
Carbylan Therapeutics, Inc.
Not Provided
Principal Investigator: Andrew N. Goldberg, MD University of California, San Francisco, Medical Center
Carbylan Therapeutics, Inc.
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP