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Could a quick In-Clinic procedure replace sinus surgery?

NCT ID NCT02533206

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether a small procedure done in the doctor's office (called EPIC) can work as well as standard sinus surgery for people with chronic sinusitis and nasal polyps. The EPIC procedure is done under local anesthesia and has a shorter recovery time. The study only includes 20 adults and is focused on seeing if a larger trial is possible, not on proving the procedure works.

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 performed in clinic under local anesthesia
What this could lead to
If successful, this could show that a simpler, in-clinic procedure works as well as surgery, reducing recovery time and healthcare costs.
What could go wrong
This is a very small pilot study (20 people) testing only recruitment and feasibility, not effectiveness. The larger trial may still fail to prove the in-clinic procedure is as good as surgery.

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

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Aug 2015

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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. 21 3. Bilateral nasal polyps present of Grade ≥ 2 on each side as determined by the Lildholdt scale score measured by nasal endoscopy (Appendix 2) at the screening visit. 4. Must have nasal blockage score greater than or equal to 4 on the sinonasal outcome test SNOT-22 (Appendix 3) at the screening visit. 5. Must have an American Society of Anesthesiologists physical status (ASA PS) 3 classification or less. ASA PS 3: Patients with severe systemic disease: Some functional limitation; has a controlled disease of more than one body system or one major system; no immediate danger of death. ASA PS 2: Patients with mild systemic disease. No functional limitations; has a well-controlled disease of one body system. ASA PS 1: Normal healthy patient. No organic, physiologic, or psychiatric disturbance; excludes the very young and very old. 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 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 FESS 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.

Contacts and locations

Locations

  • Algoma District Medical Group

    Sault Ste. Marie, Ontario, P6B 1Y5, Canada

  • Royal Victoria Hospital

    Barrie, Ontario, L4M 6M2, Canada

  • Saint Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • St Joseph's Health Care

    London, Ontario, N6A 4V2, Canada

  • The Ottawa Hospital

    Ottawa, Ontario, K1Y 4E9, Canada

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