Trial Outcomes & Findings for Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel (NCT NCT00554190)

NCT ID: NCT00554190

Last Updated: 2009-04-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 29 participants
• Primary outcome timeframe: Post-operative through 60 days
• Results posted on: 2009-04-23

Participant Flow

First subject treatment: May 2007. Last subject treatment: December 2007.

A total of 29 subjects were treated. Nineteen subjects were followed through 60 days post-treatment.

Participant milestones

Measure	AdvaCoat and Merogel AdvaCoat compared to Merogel Injectable. 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.
Overall Study STARTED	29
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	AdvaCoat and Merogel AdvaCoat compared to Merogel Injectable. 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.
Overall Study Termination forms not completed	10

Baseline Characteristics

Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

Baseline characteristics by cohort

Measure	AdvaCoat and Merogel Injectable n=29 Participants AdvaCoat compared with Merogel Injectable
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	42 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Post-operative through 60 days

Population: There were 19 participants that completed the final follow-up visit at 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.

Outcome measures

Measure	Merogel Injectable n=19 Participants Merogel Injectable compared to AdvaCoat	AdvaCoat Sinus Gel n=19 Participants AdvaCoat compared to MeroGel Injectable
Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale 0 (no visible synechia)	14 Participants	13 Participants
Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale 1 (one or several visible synechia)	4 Participants	5 Participants
Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale 2 (synechia w/ interference to sinus ventilation )	1 Participants	1 Participants
Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale 3 (complete scarring)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Post-operative through 60 days

Population: There were 19 participants who completed the 60 day follow up visits for analysis.

All reported events were coded to a standard set of terms using the MedDRA adverse event dictionary. Adverse events were listed and summarized.

Outcome measures

Measure	Merogel Injectable n=19 Participants Merogel Injectable compared to AdvaCoat	AdvaCoat Sinus Gel n=19 Participants AdvaCoat compared to MeroGel Injectable
Number of Participants With Solicited and Recorded Adverse Events Mucopurulent drainage	1 Participants	2 Participants
Number of Participants With Solicited and Recorded Adverse Events Mucopurulent drainage with polypoid swelling	2 Participants	2 Participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marcee Maroney, VP Clinical Affairs

Carbylan BioSurgery Inc.

Phone: 650 855 6774

Email: mmaroney@carbylan.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place