SinusitisNCT02975310
In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps
A study testing Endoscopic polypectomy in clinic (EPIC), Endoscopic Sinus Surgery (ESS) and General Anesthesia in people with Sinusitis and Nasal Polyps, run by Ottawa Hospital Research Institute at 4 sites in Canada.
Trial summary
Chronic rhinosinusitis, also called chronic sinusitis, is a very common life-long disease affecting over 5% of the Canadian population. Its symptoms, including daily facial pain and headache, an inability to breath through the nose and complete smell loss, regularly impair one's ability to work and to enjoy and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis, Nasal Polyps
- What is being tested?
- Endoscopic polypectomy in clinic (EPIC), Endoscopic Sinus Surgery (ESS) and General Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesCanada
- Study dates
- 11 Apr 2017to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosis of chronic rhinosinusitis with polyps requiring surgical treatment after having been treated with medical therapy as designated by the Canadian clinical practice guidelines for acute and chronic sinusitis. 15
- Bilateral nasal polyps present of Grade ≥ 2 on each side as determined by the Lildholdt scale score measured by nasal endoscopy at the screening visit.
- Must have nasal blockage score greater than or equal to 2 on the sinonasal outcome test SNOT-22 at the screening visit.
- Must have an American Society of Anesthesiologists physical status PS3 classification or less.
- Participants with comorbid asthma or chronic obstructive pulmonary disease (COPD) must have stable disease with no exacerbations (no emergency room visits, hospitalisations, or oral or parental steroid use for these lower respiratory conditions) within 3 months before the screening visit.
- Must be capable, in the opinion of the investigator, of providing informed consent to participate in the study. Participants must sign an informed consent document indicating that they understand the purpose of and procedures of the study and are willing to participate in the study.
Who cannot join
- Women who are pregnant or breast feeding as per patient's report
- Patients with hyperplastic polyps or polyps large enough that they result in external nasal deformity
- Facial pain/pressure score higher than 2 on the sinonasal outcome test SNOT-22 at the screening visit.
- History of any surgical procedure that prevents the ability to accurately grade the nasal polyps
- Participants who will not be able to complete the follow-up appointments/evaluations
- Have significant oral structural abnormalities, e.g. unrepaired cleft palate
Show all 21Show fewer
- Septal deviation requiring correction in order to perform either EPIC or ESS procedures
- 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, known peptic 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 topical lidocaine anesthetics, nasal topical 1:1000 adrenaline, nasal decongestants, nasal steroid spray
- Any serious or unstable concurrent disease, psychiatric disorder, or any significant condition that, in the opinion of the investigator, could confound the results of the study or could interfere with the participant's participation or compliance with the study
- A recent (within 1 year of the screening visit) clinically significant history of drug or alcohol abuse, or dependence that, in the opinion of the investigator could interfere 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 the treatment
- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
St. Joseph's Hospital London
London, Ontario, N6A 4V2
Taciano Rocha
taciano.rocha@sjhc.london.on.ca
- Recruiting
McGill University Health Center
Montreal, Quebec, H4A 3J1
Marc Tewfik
marc.tewfik@mcgill.ca
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 1J8
Andrea Lasso, MSc, 613-798-5555 ext. 10222, alasso@toh.ca
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
Kelly Nguyen, kelly.nguyen@alumni.ubc.ca
About this study
Official title: Endoscopic Polypectomy Performed In Clinic for Chronic Rhinosinusitis With Polyps: The EPIC Randomised Controlled Trial
Chronic rhinosinusitis, also called chronic sinusitis, is a very common life-long disease affecting over 5% of the Canadian population. Its symptoms, including daily facial pain and headache, an inability to breath through the nose and complete smell loss, regularly impair one's ability to work and to enjoy and participate in daily activities. The annual cost of chronic sinusitis to Canada is estimated at $1.3 billion while the government pays an estimated $860 million yearly for chronic sinusitis treatment. Chronic sinusitis with polyps, the most common type of chronic sinusitis, is usually treated with a combination of medications and surgery. Until now, surgical treatment has only been performed in the operating room, at a cost of about $3500 per procedure. But, recent studies have shown that a new procedure, "in-clinic polyp removal", can provide an improvement in patient symptoms to levels equal to those for sinus surgery performed in a hospital operating room. Moreover, in clinic polyp removal has additional advantages including a shorter procedure recovery time, a significantly lower cost to the health care system (about one-tenth the cost or $450), and a shorter wait time for treatment. With the proposed pragmatic trial, the investigators will determine whether the in clinic polyp removal procedure is as good as sinus surgery in the operating room at controlling patient symptoms of chronic sinusitis. The investigators will also determine the cost and health-benefits for a patient, the healthcare system and for society of in clinic polyp removal in comparison to sinus surgery done in a hospital operating room. The investigators will then know if this new treatment, in clinic polyp removal, can replace sinus surgery as the standard of care for these patients.
Read the detailed description
Chronic rhinosinusitis (CRS) is common, with a Canadian prevalence of 5%, and associated with significant morbidity having a health state utility value equivalent to end-stage renal disease. Understandably, CRS impairs workplace productivity but that productivity substantially increases following surgical treatment.
However, the wait time to receive surgical treatment (ESS) maybe up to 8 months or longer, with a cost to the Government of $3500/ESS procedure. The annual direct cost of CRS is estimated at $860 million with an overall financial impact of 1.3 billion dollars per year for Canada. Endoscopic polypectomy in clinic (EPIC), a potential disruptive innovation, is a drastically deescalated form of ESS performed in clinic instead of the operating room. EPIC appears to provide quality of life (QofL) improvement equivalent to that reported for ESS. EPIC has a shorter wait time and lower cost to a government, i.e. nearly one-tenth of ESS or about $450. A pilot economic evaluation study demonstrated that EPIC was cost-effective compared to ESS. This has created a controversy about which treatment should be employed for these patients. Further, a recent Cochrane review identified the need for high-quality randomised controlled trials to determine if ESS has additional benefit over polypectomy as there is currently insufficient evidence to draw conclusions about the superiority of polypectomy or ESS for the management of CRS with polyps.
The proposed national multicenter randomised controlled trial will determine whether EPIC is non-inferior to the current treatment standard, ESS, in QofL improvement for patients with CRS with polyps. It will also assess the cost-effectiveness of performing EPIC in place of ESS. The investigators hypothesize that EPIC will be non-inferior to ESS for QofL improvement while reducing health care cost. This would imply that EPIC is a dominant strategy and that the ESS strategy represents over-treatment in this patient population. The study findings would position EPIC into the current CRS treatment paradigm thereby transforming care and reducing costs both nationally and internationally.
- Conditions
- Sinusitis, Nasal Polyps
- Being tested
- Endoscopic polypectomy in clinic (EPIC), Endoscopic Sinus Surgery (ESS), General Anesthesia, Local and topical anesthesia
- Medical subject headings
- Sinusitis, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic polypectomy in clinic (EPIC)Procedure or surgery
The experimental intervention is endoscopic polypectomy performed in clinic (EPIC) where nasal polyps are removed using a microdebrider under local and topical anesthesia in the outpatient clinic.
Endoscopic Sinus Surgery (ESS)Procedure or surgery
The control intervention is endoscopic sinus surgery (ESS), a minimally invasive procedure that is the current standard that involves polypectomy with a microdebrider as well as sinus ostia enlargement of the affected sinuses performed in the operating room under general anesthesia.
General AnesthesiaOther
ESS will be performed under general anesthesia in the operating room
Local and topical anesthesiaOther
EPIC will be performed under topical and local anesthesia in a clinic setting
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic polypectomy in clinic (EPIC) | Experimental | Patients assigned to this arm of the study will undergo the In Clinic Polypectomy Performed in Clinic Receives: Procedure: Endoscopic polypectomy in clinic (EPIC); Other: Local and topical anesthesia |
| Endoscopic Sinus Surgery (ESS) | Active comparator | Patients assigned to this arm will undergo endoscopic sinus surgery (ESS), Receives: Procedure: Endoscopic Sinus Surgery (ESS); Other: General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinonasal Outcome Test-22 (SNOT-22)
Measured: 3 months
Secondary outcomes (6)
Peak Nasal Inspiratory Flow (PNIF):
Measured: 3 months
Iowa Satisfaction with Anesthesia Scale (ISAS)
Patient satisfaction with anesthesia for the treatment procedure
Measured: 3 months
Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP)
Work Impairment related to chronic rhinosinusitis
Measured: 3 months
EQ-5D-5L
Quality of Life
Measured: 3 months
Participant Health Resource Consumption Survey
Individual Health Resource Consumption
Measured: 3 months
Adverse Events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start11 Apr 2017
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Medtronic
- Responsible party
- Sponsor
- Investigators
- Shaun Kilty, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975310
- Sponsor's protocol ID
- CTO-0801
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2016
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kilty S, Thavorn K, Janjua A, Lee J, MacDonald K, Meen E, Micomonaco D, Rotenberg B, Sowerby LJ, Tewfik M, Adams S, Frenette H, Lasso A, Fergusson DA. Endoscopic polypectomy performed in clinic for chronic rhinosinusitis with nasal polyps: study protocol for the EPIC multicentre randomised controlled trial. BMJ Open. 2020 Dec 2;10(12):e042413. doi: 10.1136/bmjopen-2020-042413.
PubMed 33268434
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Polypectomy Performed In Clinic for Chronic Rhinosinusitis With Polyps: The EPIC Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02975310
- Acronym / sponsor ID
- CTO-0801
- Conditions
- Sinusitis, Nasal Polyps
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Medtronic
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic rhinosinusitis, also called chronic sinusitis, is a very common life-long disease affecting over 5% of the Canadian population. Its symptoms, including daily facial pain and headache, an inability to breath through the nose and complete smell loss, regularly impair one's ability to work and to enjoy and participate in daily activities. The annual cost of chronic sinusitis to Canada is estimated at $1.3 billion while the government pays an estimated $860 million yearly for chronic sinusitis treatment. Chronic sinusitis with polyps, the most common type of chronic sinusitis, is usually treated with a combination of medications and surgery. Until now, surgical treatment has only been performed in the operating room, at a cost of about $3500 per procedure. But, recent studies have shown that a new procedure, "in-clinic polyp removal", can provide an improvement in patient symptoms to levels equal to those for sinus surgery performed in a hospital operating room. Moreover, in clinic polyp removal has additional advantages including a shorter procedure recovery time, a significantly lower cost to the health care system (about one-tenth the cost or $450), and a shorter wait time for treatment. With the proposed pragmatic trial, the investigators will determine whether the in clinic polyp removal procedure is as good as sinus surgery in the operating room at controlling patient symptoms of chronic sinusitis. The investigators will also determine the cost and health-benefits for a patient, the healthcare system and for society of in clinic polyp removal in comparison to sinus surgery done in a hospital operating room. The investigators will then know if this new treatment, in clinic polyp removal, can replace sinus surgery as the standard of care for these patients.
Detailed description
Chronic rhinosinusitis (CRS) is common, with a Canadian prevalence of 5%, and associated with significant morbidity having a health state utility value equivalent to end-stage renal disease. Understandably, CRS impairs workplace productivity but that productivity substantially increases following surgical treatment.
However, the wait time to receive surgical treatment (ESS) maybe up to 8 months or longer, with a cost to the Government of $3500/ESS procedure. The annual direct cost of CRS is estimated at $860 million with an overall financial impact of 1.3 billion dollars per year for Canada. Endoscopic polypectomy in clinic (EPIC), a potential disruptive innovation, is a drastically deescalated form of ESS performed in clinic instead of the operating room. EPIC appears to provide quality of life (QofL) improvement equivalent to that reported for ESS. EPIC has a shorter wait time and lower cost to a government, i.e. nearly one-tenth of ESS or about $450. A pilot economic evaluation study demonstrated that EPIC was cost-effective compared to ESS. This has created a controversy about which treatment should be employed for these patients. Further, a recent Cochrane review identified the need for high-quality randomised controlled trials to determine if ESS has additional benefit over polypectomy as there is currently insufficient evidence to draw conclusions about the superiority of polypectomy or ESS for the management of CRS with polyps.
The proposed national multicenter randomised controlled trial will determine whether EPIC is non-inferior to the current treatment standard, ESS, in QofL improvement for patients with CRS with polyps. It will also assess the cost-effectiveness of performing EPIC in place of ESS. The investigators hypothesize that EPIC will be non-inferior to ESS for QofL improvement while reducing health care cost. This would imply that EPIC is a dominant strategy and that the ESS strategy represents over-treatment in this patient population. The study findings would position EPIC into the current CRS treatment paradigm thereby transforming care and reducing costs both nationally and internationally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic polypectomy in clinic (EPIC) | Experimental | Procedure: Endoscopic polypectomy in clinic (EPIC), Other: Local and topical anesthesiaPatients assigned to this arm of the study will undergo the In Clinic Polypectomy Performed in Clinic |
| Endoscopic Sinus Surgery (ESS) | Active comparator | Procedure: Endoscopic Sinus Surgery (ESS), Other: General AnesthesiaPatients assigned to this arm will undergo endoscopic sinus surgery (ESS), |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Diagnosis of chronic rhinosinusitis with polyps requiring surgical treatment after having been treated with medical therapy as designated by the Canadian clinical practice guidelines for acute and chronic sinusitis. 15
- Bilateral nasal polyps present of Grade ≥ 2 on each side as determined by the Lildholdt scale score measured by nasal endoscopy at the screening visit.
- Must have nasal blockage score greater than or equal to 2 on the sinonasal outcome test SNOT-22 at the screening visit.
- Must have an American Society of Anesthesiologists physical status PS3 classification or less.
Key exclusion criteria (21 listed)
- Women who are pregnant or breast feeding as per patient's report
- Patients with hyperplastic polyps or polyps large enough that they result in external nasal deformity
- Facial pain/pressure score higher than 2 on the sinonasal outcome test SNOT-22 at the screening visit.
- History of any surgical procedure that prevents the ability to accurately grade the nasal polyps
- Participants who will not be able to complete the follow-up appointments/evaluations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic polypectomy in clinic (EPIC)The experimental intervention is endoscopic polypectomy performed in clinic (EPIC) where nasal polyps are removed using a microdebrider under local and topical anesthesia in the outpatient clinic. | Procedure or surgery | Endoscopic polypectomy in clinic (EPIC) |
| Endoscopic Sinus Surgery (ESS)The control intervention is endoscopic sinus surgery (ESS), a minimally invasive procedure that is the current standard that involves polypectomy with a microdebrider as well as sinus ostia enlargement of the affected sinuses performed in the operating room under general anesthesia. | Procedure or surgery | Endoscopic Sinus Surgery (ESS) |
| General AnesthesiaESS will be performed under general anesthesia in the operating room | Other | Endoscopic Sinus Surgery (ESS) |
| Local and topical anesthesiaEPIC will be performed under topical and local anesthesia in a clinic setting | Other | Endoscopic polypectomy in clinic (EPIC) |
Primary outcome
Sinonasal Outcome Test-22 (SNOT-22)
Time frame: 3 months
6 secondary outcomes
Peak Nasal Inspiratory Flow (PNIF):
Time frame: 3 months
Iowa Satisfaction with Anesthesia Scale (ISAS)
Time frame: 3 months
Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP)
Time frame: 3 months
EQ-5D-5L
Time frame: 3 months
Participant Health Resource Consumption Survey
Time frame: 3 months
Adverse Events
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Derived from this study: PubMed 33268434Kilty S, Thavorn K, Janjua A, Lee J, MacDonald K, Meen E, Micomonaco D, Rotenberg B, Sowerby LJ, Tewfik M, Adams S, Frenette H, Lasso A, Fergusson DA. Endoscopic polypectomy performed in clinic for chronic rhinosinusitis with nasal polyps: study protocol for the EPIC multicentre randomised controlled trial. BMJ Open. 2020 Dec 2;10(12):e042413. doi: 10.1136/bmjopen-2020-042413.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shaun Kilty, MD principal investigator
Ottawa Hospital Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic polypectomy in clinic (EPIC), Endoscopic Sinus Surgery (ESS) and General Anesthesia in people with Sinusitis and Nasal Polyps, run by Ottawa Hospital Research Institute at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Lasso, MSc (6137985555 ext. 10222, alasso@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinonasal Outcome Test-22 (SNOT-22) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02975310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.