Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

NCT00554190 | Completed Phase 4 Results

• 1 other identifier: ACOT 1.0
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Ethmoid Sinusitis; Rhinosinusitis

Keywords

rhinosinusitis, ethmoid

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale

  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

  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

Study Arms (2)

1

EXPERIMENTAL

AdvaCoat compared to Merogel Injectable Bioresorbable Nasal Dressing

Device: AdvaCoat sinus gel

2

ACTIVE COMPARATOR

Merogel Injectable Bioresorbable Nasal Dressing compared to AdvaCoat

Device: Merogel Injectable

Interventions

AdvaCoat sinus gel DEVICE

A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body

1

Merogel Injectable DEVICE

Bioresorbable hyaluronic acid product

Also known as: Merogel

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who:
• Have bilateral chronic rhinosinusitis confirmed by physical exam, clinical history, and prior radiography
• Have bilateral ethmoid sinus disease
• Are scheduled for bilateral anterior or total ethmoidectomy

You may not qualify if:

• Unilateral ethmoid sinus disease
• Partial resection of middle turbinates, unilateral or bilateral

Sponsors & Collaborators

• Carbylan Therapeutics, Inc.: lead

Study Sites (4)

Alabama Nasal & Sinus Center

Birmingham, Alabama, 35242, United States

Location

University of California, San Francisco, Dept of Otolaryngology

San Francisco, California, 94143, United States

Location

Northwestern University Medical Center, Department of Otolaryngology

Chicago, Illinois, 60611, United States

Location

Cleveland Nasal Sinus & Sleep

Cleveland, Ohio, 44125, United States

Location

MeSH Terms

Conditions

Ethmoid Sinusitis; Rhinosinusitis

Condition Hierarchy (Ancestors)

Sinusitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Rhinitis

Results Point of Contact

• Title: Marcee Maroney, VP Clinical Affairs
• Organization: Carbylan BioSurgery Inc.

mmaroney@carbylan.com

650 855 6774

Study Officials

• Andrew N. Goldberg, MD

  University of California, San Francisco, Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 6, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 23, 2009
• Results First Posted: April 23, 2009

Record last verified: 2009-03

Locations

US (4)