ClinicalTrials.gg
RecruitingNCT02975310Updated Dec 30, 2025

In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps

An interventional study of Endoscopic polypectomy in clinic (EPIC) and Endoscopic Sinus Surgery (ESS) in Sinusitis and Nasal Polyps, sponsored by Ottawa Hospital Research Institute. Recruiting at 4 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Apr 2017; still recruiting 9 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sinusitis
  • Nasal Polyps
03

In context

Sinusitis

256 studies on the registry are indexed under Sinusitis; 23 are open to participants now.

This study's planned enrollment of 140 is above the median of 60 across 196 interventional studies indexed under Sinusitis.

Browse Sinusitis studies →

Lead sponsor

Ottawa Hospital Research Institute is the lead sponsor of 547 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 years or older
  2. 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
  3. 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.
  4. Must have nasal blockage score greater than or equal to 2 on the sinonasal outcome test SNOT-22 at the screening visit.
  5. Must have an physical status PS3 classification or less.
  6. Participants with comorbid asthma or (COPD) must have stable disease with no exacerbations (no emergency room visits, hospitalisations, or oral or parental use for these lower respiratory conditions) within 3 months before the screening visit.
  7. Must be capable, in the opinion of the investigator, of providing 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.

Exclusion criteria

Exclusion Criteria:

  1. Women who are pregnant or breast feeding as per patient's report
  2. Patients with hyperplastic polyps or polyps large enough that they result in external nasal deformity
  3. Facial pain/pressure score higher than 2 on the sinonasal outcome test SNOT-22 at the screening visit.
  4. History of any surgical procedure that prevents the ability to accurately grade the nasal polyps
  5. Participants who will not be able to complete the follow-up appointments/evaluations
  6. Have significant oral structural abnormalities, e.g. unrepaired cleft palate
  7. Septal deviation requiring correction in order to perform either EPIC or ESS procedures
  8. Diagnosis of an immunodeficiency or state
  9. Diagnosis of cystic fibrosis
  10. Diagnosis of allergic fungal sinusitis
  11. to the use of oral (e.g. uncontrolled diabetes, congestive heart failure, uncontrolled hypertension, known renal insufficiency, known peptic ulcer disease, known glaucoma, pregnancy)
  12. History of either Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis (e.g. granulomatosis with polyangiitis(GPA))
  13. Allergy, , or contraindication to the use of local or topical lidocaine anesthetics, nasal topical 1:1000 adrenaline, nasal decongestants, nasal steroid spray
  14. 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
  15. A recent (within 1 year of the screening visit) 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
  16. Inability to read and understand English
  17. Any medical condition that in the opinion of the investigator would interfere with the treatment
  18. Any participant who is unfit to undergo surgery under general anesthesia
  19. Current participation in another clinical trial at the time of the screening visit.
  20. Participant is unable to undergo an awake procedure
  21. Diagnosis or Aspirin Exacerbated Respiratory Disease (AERD)
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Endoscopic polypectomy in clinic (EPIC)

    Patients assigned to this arm of the study will undergo the In Clinic Polypectomy Performed in Clinic

    Procedure: Endoscopic polypectomy in clinic (EPIC) · Other: Local and topical anesthesia

  • Active comparator
    Endoscopic Sinus Surgery (ESS)

    Patients assigned to this arm will undergo endoscopic sinus surgery (ESS),

    Procedure: Endoscopic Sinus Surgery (ESS) · Other: General Anesthesia

Interventions

  • ProcedureEndoscopic 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.

  • ProcedureEndoscopic 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.

  • OtherGeneral Anesthesia

    ESS will be performed under general anesthesia in the operating room

  • OtherLocal and topical anesthesia

    EPIC will be performed under topical and local anesthesia in a clinic setting

06

What researchers measure

Primary outcomes

  1. Sinonasal Outcome Test-22 (SNOT-22)

    Time frame: 3 months

Secondary outcomes

  1. Peak Nasal Inspiratory Flow (PNIF):

    Time frame: 3 months

  2. Iowa Satisfaction with Anesthesia Scale (ISAS)

    Patient satisfaction with anesthesia for the treatment procedure

    Time frame: 3 months

  3. Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP)

    Work Impairment related to chronic rhinosinusitis

    Time frame: 3 months

  4. EQ-5D-5L

    Quality of Life

    Time frame: 3 months

  5. Participant Health Resource Consumption Survey

    Individual Health Resource Consumption

    Time frame: 3 months

  6. Adverse Events

    Time frame: 3 months

Other outcomes

  1. Lund-Kennedy Endoscopic Scoring Scale

    Endoscopic inflammation of the nose and paranasal sinuses after treatment

    Time frame: 3 months

  2. Visual Analogue Scale (VAS) for satisfaction with assigned procedure

    Satisfaction with assigned procedure

    Time frame: 3 months

07

Study locations

4 of 4 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02975310
Collaborators
Canadian Institutes of Health Research (CIHR), Medtronic
Responsible party
Sponsor
First posted
Nov 29, 2016
Start date
Apr 11, 2017
Primary completion
Dec 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 30, 2025

Study contacts

Andrea Lasso, MSc
Contact
alasso@toh.ca
6137985555 ext. 10222
Shaun Kilty, MD
principal investigator · Ottawa Hospital Research Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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