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Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00912405
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : April 20, 2015
Last Update Posted : April 20, 2015
Sponsor:
Information provided by (Responsible Party):
Intersect ENT

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Chronic Sinusitis
Intervention Device: Steroid-Eluting Sinexus Intranasal Splint
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sinexus Intranasal Splint
Hide Arm/Group Description

Patient receives a drug-coated intranasal splint

Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)

Period Title: Overall Study
Started 50
Completed 45
Not Completed 5
Reason Not Completed
Lost to Follow-up             5
Arm/Group Title Sinexus Intranasal Splint
Hide Arm/Group Description

Patient receives a drug-coated intranasal splint

Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)

Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
44.2  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
24
  48.0%
Male
26
  52.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
Lund MacKay CT Stage   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants
11.2  (5.5)
[1]
Measure Description: The Lund Mackay CT Staging system is a scale ranging from 0 to 24, where lower scores represent a better condition. each sinus is scored 0, 1 or 2, where 0=no opacification, 1=partial opacification and 2=complete opacification. 12 areas of the anatomy are evaluated, resulting in the scale ranging from 0 to 24.
Proportion of Patients with Polyps  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants
33
Proportion of Patients Undergoing Revision Surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants
14
1.Primary Outcome
Title Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sinexus Intranasal Splint
Hide Arm/Group Description:

Patient receives a drug-coated intranasal splint

Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)

Overall Number of Participants Analyzed 50
Overall Number of Units Analyzed
Type of Units Analyzed: Number of sinuses
90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Number of Sinuses
6
(2.49 to 13.95)
2.Primary Outcome
Title Device Placement Success Rate
Hide Description A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.
Time Frame At the time of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sinexus Intranasal Splint
Hide Arm/Group Description:

Patient receives a drug-coated intranasal splint

Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)

Overall Number of Participants Analyzed 50
Overall Number of Units Analyzed
Type of Units Analyzed: Sinuses Attempted
90
Measure Type: Number
Unit of Measure: Sinuses
90
3.Secondary Outcome
Title Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities
Hide Description 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.
Time Frame Baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sinexus Intranasal Splint
Hide Arm/Group Description:

Patient receives a drug-coated intranasal splint

Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)

Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: Pts. w/ significant IOP elevation
0
4.Secondary Outcome
Title Number of Sinuses With Significant Post-operative Adhesion Formation
Hide Description 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.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sinexus Intranasal Splint
Hide Arm/Group Description:

Patient receives a drug-coated intranasal splint

Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)

Overall Number of Participants Analyzed 50
Overall Number of Units Analyzed
Type of Units Analyzed: Sinuses
90
Measure Type: Number
Unit of Measure: sinuses
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sinexus Intranasal Splint
Hide Arm/Group Description

Patient receives a drug-coated intranasal splint

Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)

All-Cause Mortality
Sinexus Intranasal Splint
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Sinexus Intranasal Splint
Affected / at Risk (%) # Events
Total   3/50 (6.00%)    
Gastrointestinal disorders   
Diverticulitis   1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
Sinusitis   2/50 (4.00%)  2
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sinexus Intranasal Splint
Affected / at Risk (%) # Events
Total   23/50 (46.00%)    
General disorders   
Headache  5/50 (10.00%)  5
Respiratory, thoracic and mediastinal disorders   
Sinusitis  18/50 (36.00%)  18
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James Stambaugh
Organization: Intersect ENT
Phone: 650-641-2103
EMail: jstambaugh@intersectent.com
Layout table for additonal information
Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT00912405    
Other Study ID Numbers: P500-0209
First Submitted: June 1, 2009
First Posted: June 3, 2009
Results First Submitted: October 23, 2014
Results First Posted: April 20, 2015
Last Update Posted: April 20, 2015