Last updated: September 20, 2022
Sponsor: Ottawa Hospital Research Institute
Overall Status: Active - Recruiting
Phase
N/A
Condition
Rhinitis, Allergic, Perennial
Sinusitis
Polyps
Treatment
N/AClinical Study ID
NCT02975310
CTO-0801
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18 years or older
- Diagnosis of chronic rhinosinusitis with polyps requiring surgical treatment afterhaving been treated with medical therapy as designated by the Canadian clinicalpractice guidelines for acute and chronic sinusitis. 15
- Bilateral nasal polyps present of Grade ≥ 2 on each side as determined by theLildholdt scale score measured by nasal endoscopy at the screening visit.
- Must have nasal blockage score greater than or equal to 2 on the sinonasal outcometest SNOT-22 at the screening visit.
- Must have an American Society of Anesthesiologists physical status PS3 classificationor less.
- Participants with comorbid asthma or chronic obstructive pulmonary disease (COPD) musthave stable disease with no exacerbations (no emergency room visits, hospitalisations,or oral or parental steroid use for these lower respiratory conditions) within 3months before the screening visit.
- Must be capable, in the opinion of the investigator, of providing informed consent toparticipate in the study. Participants must sign an informed consent documentindicating that they understand the purpose of and procedures of the study and arewilling to participate in the study.
Exclusion
Exclusion Criteria:
- Women who are pregnant or breast feeding as per patient's report
- Patients with hyperplastic polyps or polyps large enough that they result in externalnasal deformity
- Facial pain/pressure score higher than 2 on the sinonasal outcome test SNOT-22 at thescreening visit.
- History of any surgical procedure that prevents the ability to accurately grade thenasal polyps
- Participants who will not be able to complete the follow-up appointments/evaluations
- Have significant oral structural abnormalities, e.g. unrepaired cleft palate
- Septal deviation requiring correction in order to perform either EPIC or ESSprocedures
- Diagnosis of an immunodeficiency or immunocompromised state
- Diagnosis of cystic fibrosis
- Diagnosis of allergic fungal sinusitis
- Contraindication to the use of oral corticosteroids (e.g. uncontrolled diabetes,congestive heart failure, uncontrolled hypertension, known renal insufficiency, knownpeptic ulcer disease, known glaucoma, pregnancy)
- History of either Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis (e.g. granulomatosis with polyangiitis(GPA))
- Allergy, hypersensitivity, or contraindication to the use of local or topicallidocaine anesthetics, nasal topical 1:1000 adrenaline, nasal decongestants, nasalsteroid spray
- Any serious or unstable concurrent disease, psychiatric disorder, or any significantcondition that, in the opinion of the investigator, could confound the results of thestudy or could interfere with the participant's participation or compliance with thestudy
- A recent (within 1 year of the screening visit) clinically significant history of drugor alcohol abuse, or dependence that, in the opinion of the investigator couldinterfere with the participant's participation or compliance with the study
- Inability to read and understand English
- Any medical condition that in the opinion of the investigator would interfere with thetreatment
- Any participant who is unfit to undergo surgery under general anesthesia
- Current participation in another clinical trial at the time of the screening visit.
- Participant is unable to undergo an awake procedure
- Diagnosis or Aspirin Exacerbated Respiratory Disease (AERD)
Study Design
Total Participants: 140
Study Start date:
April 11, 2017
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Vancouver General Hospital
Vancouver, British Columbia
CanadaActive - Recruiting
St. Joseph's Hospital London
London, Ontario N6A 4V2
CanadaActive - Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario K1Y 1J8
CanadaActive - Recruiting
McGill University Health Center
Montréal, Quebec H4A 3J1
CanadaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.