Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

April 22, 2009 updated by: Carbylan Therapeutics, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35242
        • Alabama Nasal & Sinus Center
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco, Dept of Otolaryngology
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Medical Center, Department of Otolaryngology
    • Ohio
      • Cleveland, Ohio, United States, 44125
        • Cleveland Nasal Sinus & Sleep

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AdvaCoat compared to Merogel Injectable Bioresorbable Nasal Dressing
Device: AdvaCoat sinus gel
A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body
Active Comparator: 2
Merogel Injectable Bioresorbable Nasal Dressing compared to AdvaCoat
Device: Merogel Injectable
Bioresorbable hyaluronic acid product
Other Names:
  • Merogel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale
Time Frame: Post-operative through 60 days
Synechia (adhesion) scale range of 0 = No visible synechia to 3 = Complete scarring between the middle turbinate and lateral nasal wall was used in the assessment.
Post-operative through 60 days
Number of Participants With Solicited and Recorded Adverse Events
Time Frame: Post-operative through 60 days
All reported events were coded to a standard set of terms using the MedDRA adverse event dictionary. Adverse events were listed and summarized.
Post-operative through 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carbylan Therapeutics, Inc.

Investigators

  • Principal Investigator: Andrew N. Goldberg, MD, University of California, San Francisco, Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 2, 2007

First Submitted That Met QC Criteria

November 2, 2007

First Posted (Estimate)

November 6, 2007

Study Record Updates

Last Update Posted (Estimate)

April 23, 2009

Last Update Submitted That Met QC Criteria

April 22, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACOT 1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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