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Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

NCT00554190 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2009-04-23

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Carbylan Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew N. Goldberg, MD · University of California, San Francisco, Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00554190 on ClinicalTrials.gov