Ethmoid SinusitisPhase 4NCT00554190
Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel
A Phase 4 study testing AdvaCoat sinus gel and Merogel Injectable in people with Ethmoid Sinusitis and Rhinosinusitis, run by Carbylan Therapeutics, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ethmoid Sinusitis, Rhinosinusitis
- What is being tested?
- AdvaCoat sinus gel and Merogel Injectable
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2007to Dec 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unilateral ethmoid sinus disease
- Partial resection of middle turbinates, unilateral or bilateral
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Alabama Nasal & Sinus Center
Birmingham, Alabama, 35242
Northwestern University Medical Center, Department of Otolaryngology
Chicago, Illinois, 60611
Cleveland Nasal Sinus & Sleep
Cleveland, Ohio, 44125
University of California, San Francisco, Dept of Otolaryngology
San Francisco, California, 94143
About this study
Official title: 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.
Read the 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.
- Conditions
- Ethmoid Sinusitis, Rhinosinusitis
- Being tested
- AdvaCoat sinus gel, Merogel Injectable
- Keywords
- rhinosinusitis, ethmoid
- Medical subject headings
- Ethmoid Sinusitis, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvaCoat sinus gelDevice
A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body
Merogel InjectableDevice
Also called Merogel
Bioresorbable hyaluronic acid product
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AdvaCoat compared to Merogel Injectable Bioresorbable Nasal Dressing Receives: Device: AdvaCoat sinus gel |
| 2 | Active comparator | Merogel Injectable Bioresorbable Nasal Dressing compared to AdvaCoat Receives: Device: Merogel Injectable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post-operative through 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ethmoid SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carbylan Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew N. Goldberg, MD, Principal investigator, University of California, San Francisco, Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554190
- Sponsor's protocol ID
- ACOT 1.0
- Status last verified
- Mar 2009
- First submitted
- 2 Nov 2007
- Last updated
- 23 Apr 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Randomized, Controlled, Subject-Blinded Study to Evaluate the Safety and Effectiveness of AdvaCoat Sinus Gel Following Endoscopic Ethmoid Sinus Surgery
- ClinicalTrials.gov ID
- NCT00554190
- Acronym / sponsor ID
- ACOT 1.0
- Conditions
- Ethmoid Sinusitis, Rhinosinusitis
- Keywords
- rhinosinusitis, ethmoid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Carbylan Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Nov 2007 (estimated)
- Results
- Posted 23 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: AdvaCoat sinus gelAdvaCoat compared to Merogel Injectable Bioresorbable Nasal Dressing |
| 2 | Active comparator | Device: Merogel InjectableMerogel Injectable Bioresorbable Nasal Dressing compared to AdvaCoat |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unilateral ethmoid sinus disease
- Partial resection of middle turbinates, unilateral or bilateral
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdvaCoat sinus gelA sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body | Device | 1 |
| Merogel InjectableAlso: MerogelBioresorbable hyaluronic acid product | Device | 2 |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Ethmoid Sinusitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew N. Goldberg, MD principal investigator
University of California, San Francisco, Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AdvaCoat sinus gel and Merogel Injectable in people with Ethmoid Sinusitis and Rhinosinusitis, run by Carbylan Therapeutics, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale (time frame: Post-operative through 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2009.