Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus
NCT ID: NCT02266810
Last Updated: 2018-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
160 participants
INTERVENTIONAL
2014-09-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PROPEL Mini Sinus Implant
Propel Mini placed in frontal sinus opening following ESS
PROPEL Mini Sinus Implant.
Placement of sinus implant following frontal sinus surgery
Sinus Surgery alone: cohort 1
Sinus Surgery only: cohort 1: ESS with standard post-operative care.
Sinus Surgery alone
Sinus surgery only, without implant placement
PROPEL Nova Sinus Implant
Propel Nova placed in frontal sinus opening following ESS
Propel Nova Sinus Implant
Placement of sinus implant following frontal sinus surgery
Sinus Surgery alone: cohort 2
Sinus Surgery only: cohort 2: ESS with standard post-operative care.
Sinus Surgery alone
Sinus surgery only, without implant placement
Interventions
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PROPEL Mini Sinus Implant.
Placement of sinus implant following frontal sinus surgery
Sinus Surgery alone
Sinus surgery only, without implant placement
Propel Nova Sinus Implant
Placement of sinus implant following frontal sinus surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has a clinical indication for and has consented to ESS including bilateral frontal sinus surgery.
* Chronic sinusitis diagnosis confirmed and documented by CT scan within 6 months of the procedure.
* Patient has bilateral disease in both frontal sinuses confirmed by Lund-Mackay score of ≥1 on each side.
* Planned sinus surgery includes bilateral ethmoidectomy (if judged necessary) and frontal sinus enlargement using Draf II (A or B) dissection or balloon dilation, with minimum of 5-mm diameter opening created.
* Technique used for frontal sinus surgery is the same on both sides (e.g. surgical dissection alone bilaterally, balloon dilation alone bilaterally, or both bilaterally)
* Septoplasty for access to the ostio-meatal complex is permitted.
* ESS including bilateral frontal sinus surgery has been successfully completed without significant complication that, in the opinion of the investigator, would confound study results, and the patient's anatomy remains amenable to implant placement.
Exclusion Criteria
* Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or asthma or other condition
* Known history of allergy or intolerance to corticosteroids or mometasone furoate
* Clinical evidence of acute bacterial sinusitis
* Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)
* Active viral illness
* Concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease
* Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90 day follow-up period
* Currently participating in another clinical trial
* History of insulin dependent diabetes mellitus
* Patient has previously undergone ESS and experienced a CSF leak or has compromised vision as a result of a complication in a prior ESS procedure
* Significant complication during the current frontal sinus surgery procedure such as excessive blood loss, CSF leak or punctured lamina papyracea
* Current ESS including frontal sinus surgery is aborted for any reason.
* At least one side is not amenable for implant placement.
18 Years
ALL
No
Sponsors
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Advance Research Associates
OTHER
Intersect ENT
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy L. Smith, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Amber U. Luong, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Sacramento Ear, Nose and Throat
Sacramento, California, United States
Breathe Clear Institute of Sinus and Allergy Relief
Torrance, California, United States
The Connecticut Center for Advanced ENT Care
Norwalk, Connecticut, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
ENT of Georgia
Atlanta, Georgia, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
Albany ENT and Allergy
Albany, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
East Virginia Medical School
Norfolk, Virginia, United States
Countries
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References
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Smith TL, Singh A, Luong A, Ow RA, Shotts SD, Sautter NB, Han JK, Stambaugh J, Raman A. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016 Dec;126(12):2659-2664. doi: 10.1002/lary.26140. Epub 2016 Jul 1.
Luong A, Ow RA, Singh A, Weiss RL, Han JK, Gerencer R, Stolovitzky JP, Stambaugh JW, Raman A. Safety and Effectiveness of a Bioabsorbable Steroid-Releasing Implant for the Paranasal Sinus Ostia: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Jan;144(1):28-35. doi: 10.1001/jamaoto.2017.1859. Epub 2017 Nov 2.
Other Identifiers
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P500-0514
Identifier Type: -
Identifier Source: org_study_id
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