CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 29 enrolled
Drug / intervention
AdvaCoat sinus gel +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00554190
NCT00554190Phase 4Completed
CompareCT.gov

A Prospective, Multi-Center, Randomized, Controlled, Subject-Blinded Study to Evaluate the Safety and Effectiveness of AdvaCoat Sinus Gel Following Endoscopic Ethmoid Sinus Surgery

Carbylan Therapeutics, Inc.·interventional·Posted Nov 6, 2007·Updated Apr 23, 2009

In Brief

A Phase 4 clinical trial evaluating AdvaCoat sinus gel and Merogel Injectable for Ethmoid Sinusitis and Rhinosinusitis. Completed, enrolled 29 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEthmoid Sinusitis, Rhinosinusitis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2007
Enrollment StartMay 1, 2007
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.7 years ago

Interventions

AdvaCoat sinus geldevice

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

Merogel Injectabledevice

Bioresorbable hyaluronic acid product