Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
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|ClinicalTrials.gov Identifier: NCT00912405|
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : April 20, 2015
Last Update Posted : April 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Sinusitis||Device: Steroid-Eluting Sinexus Intranasal Splint||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||December 2009|
Experimental: Sinexus Intranasal Splint
Patient receives a drug-coated intranasal splint
Device: Steroid-Eluting Sinexus Intranasal Splint
Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
- Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT) [ Time Frame: 30 days ]
- Device Placement Success Rate [ Time Frame: At the time of procedure ]A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.
- Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities [ Time Frame: Baseline and 30 days ]Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified.
- Number of Sinuses With Significant Post-operative Adhesion Formation [ Time Frame: 30 days ]Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912405
|United States, California|
|Central California Ear, Nose Thraot|
|Fresno, California, United States|