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Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia (EXCEED)

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ClinicalTrials.gov Identifier: NCT02228720
Recruitment Status : Completed
First Posted : August 29, 2014
Results First Posted : August 4, 2017
Last Update Posted : August 4, 2017
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: Device Feasibility
Condition Chronic Sinusitis
Intervention Device: Propel Nova Sinus Implant
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Propel Nova Sinus Implant
Hide Arm/Group Description

Sinus stent with steroid coating (370 ug mometasone furoate)

Propel Nova Sinus Implant: Sinus stent with steroid coating (370 ug mometasone furoate)

Period Title: Open Label - Baseline
Started 15
Completed 15
Not Completed 0
Period Title: Open Label - Day 30
Started 15
Completed 14
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Period Title: Open Label - Day 90
Started 14
Completed 14
Not Completed 0
Arm/Group Title Propel Nova Sinus Implant
Hide Arm/Group Description Steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
All patients and sinuses in whom placement of a Propel Nova Sinus Implant was attempted.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
50.6  (13.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
2
  13.3%
Male
13
  86.7%
Lund-Mackay Score (CT scan)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants
Frontal Sinuses 2.5  (1.19)
Maxillary Sinuses 2.3  (0.98)
[1]
Measure Description: The severity of sinus mucosal inflammation or fluid accumulation scored as 0 (complete lucency), 1 (partial lucency) or 2 (complete opacity).
1.Primary Outcome
Title Device Placement Success Rate
Hide Description Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.
Time Frame Baseline Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Attempted frontal and maxillary sinus ostia
Arm/Group Title Propel Nova Sinus Implant
Hide Arm/Group Description:
Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
Overall Number of Participants Analyzed 15
Overall Number of Units Analyzed
Type of Units Analyzed: Sinuses
45
Measure Type: Number
Unit of Measure: Percentage of attempted sinuses
Frontal Sinuses Number Analyzed 24 Sinuses
100
Maxillary Sinuses Number Analyzed 21 Sinuses
95.2
2.Secondary Outcome
Title Ostial Patency
Hide Description Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)
Time Frame Baseline, Day 30, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Frontal and maxillary sinus ostia
Arm/Group Title Propel Nova Sinus Implant
Hide Arm/Group Description:
Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
Overall Number of Participants Analyzed 15
Overall Number of Units Analyzed
Type of Units Analyzed: Sinuses
45
Measure Type: Number
Unit of Measure: percentage of evaluable sinuses
Baseline - Frontal Sinuses Number Analyzed 24 Sinuses
33.3
Day 30 - Frontal Sinuses Number Analyzed 22 Sinuses
100
Day 90 - Frontal Sinuses Number Analyzed 17 Sinuses
88.2
Baseline - Maxillary Sinuses Number Analyzed 21 Sinuses
57.1
Day 30 - Maxillary Sinuses Number Analyzed 21 Sinuses
100
Day 90 - Maxillary Sinuses Number Analyzed 17 Sinuses
94.1
3.Secondary Outcome
Title Adhesion/Scarring Grade 2 & 3
Hide Description Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)
Time Frame Baseline, Day 30, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Frontal and maxillary sinus ostia
Arm/Group Title Propel Nova Sinus Implant
Hide Arm/Group Description:
Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
Overall Number of Participants Analyzed 15
Overall Number of Units Analyzed
Type of Units Analyzed: Sinuses
45
Measure Type: Number
Unit of Measure: percentage of evaluable sinuses
Baseline - Frontal Sinuses Number Analyzed 24 Sinuses
33.4
Day 30 - Frontal Sinuses Number Analyzed 22 Sinuses
4.5
Day 90 - Frontal Sinuses Number Analyzed 17 Sinuses
11.8
Baseline - Maxillary Sinuses Number Analyzed 21 Sinuses
19.1
Day 30 - Maxillary Sinuses Number Analyzed 21 Sinuses
0
Day 90 - Maxillary Sinuses Number Analyzed 19 Sinuses
5.3
4.Secondary Outcome
Title Degree of Inflammation
Hide Description Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)
Time Frame Baseline, Day 30, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Frontal and maxillary sinus ostia
Arm/Group Title Propel Nova Sinus Implant
Hide Arm/Group Description:
Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
Overall Number of Participants Analyzed 15
Overall Number of Units Analyzed
Type of Units Analyzed: Sinuses
45
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline - Frontal Sinuses Number Analyzed 24 Sinuses
62.8  (23.14)
Day 30 - Frontal Sinuses Number Analyzed 22 Sinuses
28.1  (23.24)
Day 90 - Frontal Sinuses Number Analyzed 17 Sinuses
25.0  (25.23)
Baseline - Maxillary Sinuses Number Analyzed 21 Sinuses
51.6  (24.94)
Day 30 - Maxillary Sinuses Number Analyzed 21 Sinuses
22.2  (13.55)
Day 90 - Maxillary Sinuses Number Analyzed 19 Sinuses
14.1  (21.6)
5.Secondary Outcome
Title Sino-Nasal Outcome Test (SNOT) 22
Hide Description Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110
Time Frame Baseline, Day 30, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Adult patients (≥ 18 years of age) diagnosed with chronic sinusitis with or without nasal/sinus polyposis who are candidates for endoscopic sinus surgery and in whom placement of the Propel Nova Sinus Implant is both feasible and medically appropriate
Arm/Group Title Propel Nova Sinus Implant
Hide Arm/Group Description:
Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 15 participants
42.6  (14.9)
Day 30 Number Analyzed 14 participants
21.5  (19.0)
Day 90 Number Analyzed 14 participants
20.6  (19.3)
Time Frame Day 90
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Propel Nova Sinus Implant
Hide Arm/Group Description Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
All-Cause Mortality
Propel Nova Sinus Implant
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Propel Nova Sinus Implant
Affected / at Risk (%) # Events
Total   1/15 (6.67%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Squamous Cell Carcinoma *  1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Propel Nova Sinus Implant
Affected / at Risk (%) # Events
Total   9/15 (60.00%)    
General disorders   
Vasovagal Reaction *  1/15 (6.67%)  1
Infections and infestations   
Acute Sinusitis *  1/15 (6.67%)  1
Upper Respiratory Infection *  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
Bronchitis *  1/15 (6.67%)  1
Chronic Sinusitis *  1/15 (6.67%)  1
Nasal Congestion *  3/15 (20.00%)  3
Nasal polyps *  1/15 (6.67%)  1
Sinus Drainage, green *  1/15 (6.67%)  1
Crusting in nares *  1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
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: 6506412103
EMail: jstambaugh@intersectent.com
Layout table for additonal information
Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT02228720    
Other Study ID Numbers: P500-0414
First Submitted: June 25, 2014
First Posted: August 29, 2014
Results First Submitted: August 23, 2016
Results First Posted: August 4, 2017
Last Update Posted: August 4, 2017