In-Clinic polyp removal could replace costly sinus surgery
NCT ID NCT02975310
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two ways to treat chronic sinusitis with nasal polyps: a new in-clinic procedure done under local anesthesia versus standard sinus surgery in an operating room. Researchers will enroll 140 adults to see if the in-clinic approach controls symptoms just as well, while being faster, cheaper, and easier to access. If successful, it could become the new standard of care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- endoscopic polypectomy in clinic (polyp removal using a microdebrider under local anesthesia)
- What this could lead to
- If it works, this could replace expensive sinus surgery with a cheaper, quicker in-clinic procedure for many patients with nasal polyps.
- What could go wrong
- This is a mid-stage trial with 140 participants, so results may not apply to everyone. The in-clinic procedure may not control symptoms as well as surgery in the long run.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2017
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 American Society of Anesthesiologists physical status PS3 classification or less. 6. 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. 7. 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. 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 immunocompromised state 9. Diagnosis of cystic fibrosis 10. Diagnosis of allergic fungal sinusitis 11. 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) 12. History of either Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis (e.g. granulomatosis with polyangiitis(GPA)) 13. Allergy, hypersensitivity, 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) 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 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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McGill University Health Center
RECRUITINGMontreal, Quebec, H4A 3J1, Canada
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Ottawa Hospital Research Institute
RECRUITINGOttawa, Ontario, K1Y 1J8, Canada
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St. Joseph's Hospital London
RECRUITINGLondon, Ontario, N6A 4V2, Canada
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Vancouver General Hospital
RECRUITINGVancouver, British Columbia, Canada
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