SinusitisNCT02533206
Pilot Study of The EPIC Trial
A study testing Endoscopic Polypectomy Performed in Clinic and Functional Endoscopic Sinus Surgery (FESS) in people with Sinusitis and Nasal Polyps, run by Ottawa Hospital Research Institute at 5 sites in Canada.
Trial summary
Chronic sinusitis is one of the most common chronic diseases in North America, with over 5% of the Canadian population affected by the disease. Until now, treatment with surgery has been performed only in the operating room. 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 Performed in Clinic and Functional Endoscopic Sinus Surgery (FESS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesCanada
- Study dates
- Aug 2015to Dec 2025
- 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. 21
- 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.
- Must have nasal blockage score greater than or equal to 4 on the sinonasal outcome test SNOT-22 (Appendix 3) at the screening visit.
- 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.
- 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
- 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 FESS 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
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2
St Joseph's Health Care
London, Ontario, N6A 4V2
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Algoma District Medical Group
Sault Ste. Marie, Ontario, P6B 1Y5
Saint Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: Endoscopic Polypectomy Performed In Clinic (EPIC) for Chronic Rhinosinusitis With Polyps: Pilot Study of The EPIC Randomised Controlled Trial
Chronic sinusitis is one of the most common chronic diseases in North America, with over 5% of the Canadian population affected by the disease. Until now, treatment with surgery has been performed only in the operating room. Recently a smaller surgical procedure that is done in the clinic for some patients with chronic sinusitis with polyps has been found to result in symptom control that appears to be similar to that which occurs with sinus surgery. Performing the smaller clinical procedure has advantages including a shorter recovery time for the patient, a much lower cost to the health care system for the procedure, and a shorter patient wait time for the procedure to be done in comparison to sinus surgery performed in the operating room. To know with greater certainty that the procedure performed in the clinic is as good as the operating room sinus surgery, a large multiple investigator randomised clinical trial has been designed. However, before carrying out that trial, a practice run or internal pilot study of that trial is required to ensure that the trial can recruit patients at the rate that is anticipated and that the procedures to obtain the measurements being used for the larger study are adequate.
Read the detailed description
For the proposed internal pilot study 20 patients who consent to participate and meet all inclusion criteria and none of the inclusion criteria will be enrolled. The internal pilot study will be carried out at sites located in Ottawa , Winchester, Toronto, Barrie, Sault Saint Marie and London Ontario. A total of 7 investigator-surgeons will participate. Since this is an internal pilot study a sample size was not calculated, rather, the 20 patients enrolled in the internal pilot study will be included as part of the total sample of the definite non-inferiority trial, which has been calculated to be 140 patients. The pilot will recruit 15% of the total sample which is sufficient to achieve the main goal of this pilot i.e. establish the feasibility of the main trial. Eligible participants will be randomly assigned in a 1:1 fashion to either the experimental (endoscopic polypectomy performed in clinic, EPIC) or the control group (functional endoscopic sinus surgery, FESS) . Patients will be allocated to treatment group using web-based central randomization to protect against bias , these data will be used to confirm the design the non-inferiority randomized control trial.
Duration of treatment period For both experimental (endoscopic polypectomy performed in clinic, EPIC) and control (functional endoscopic sinus surgery, FESS) groups, the day the treatment is completed will be considered to be time "0". There is no change to either procedure related to the participant having enrolled into the study. After the treatment day, participants will enter a follow-up period where the final study related evaluation is 90(± 5) days following their procedure.
Frequency and duration of follow up Enrolled participants will be re-evaluated by the investigators after their procedure twice, which is the normal frequency of visits for postoperative care for patients who have undergone surgical treatment for chronic rhinosinusitis with polyps. The first follow-up evaluation at 15 days (± 5 days) following the procedure and the last will occur 90 days (± 5 days) following the treatment. The last follow-up is chosen to be at 90 days given the primary outcome measure of interest is the sinonasal outcome test-22 (SNOT-22) score. Three months after treatment the SNOT-22 does not appear to change substantially with further follow-up. A landmark study completed by Hopkins et al. (2006) with a cohort of over 3000 patients who had undergone endoscopic sinus surgery for chronic sinusitis and who were followed for 36 months demonstrated that the sinonasal outcome test SNOT-22 scores at 3 months following surgery were not different from those measured at 12 or 36 months. Therefore, the 3-month (90 days) follow-up has been specifically chosen for this study given the primary outcome measure being used is also the SNOT-22 score.
Long Term Follow up:
After the second follow up visit, patients will enter a long term follow-up period which will last 5 years. During this period, patients will receive the following questionnaires via mail: SNOT-22, EuroQol (EQ-5D-5L) questionnaire, work productivity and impairment questionnaire (WPAI), Satisfaction Survey and the Individual Health Resource Consumption. These questionnaires will be mailed at 6 months, 1,2,3,4 and 5 years after the procedure. At this time patients will also be asked if they have had additional surgeries for their chronic rhinosinusitis with nasal polyps
- Conditions
- Sinusitis, Nasal Polyps
- Being tested
- Endoscopic Polypectomy Performed in Clinic, Functional Endoscopic Sinus Surgery (FESS)
- 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 Performed in ClinicProcedure or surgery
Also called EPIC
Endoscopic polypectomy performed in clinic under local and topical anesthesia
Functional Endoscopic Sinus Surgery (FESS)Procedure or surgery
Also called FESS
Functional Endoscopic Sinus Surgery
| Study group | Role | What they receive |
|---|---|---|
| EPIC | Experimental | 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. The participant will be discharged home from the clinic following their procedure. Receives: Procedure: Endoscopic Polypectomy Performed in Clinic |
| FESS | Active comparator | The control intervention is functional endoscopic sinus surgery (FESS), 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 Receives: Procedure: Functional Endoscopic Sinus Surgery (FESS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment
Number of patients recruited in one year
Measured: One year
Secondary outcomes (2)
Arm cross-over
Number of participants who switched arm
Measured: One year
Loss to follow up
Number of participants who do not complete the 6 month follow up period
Measured: Evaluated at 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2022
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaun Kilty, MD, FRCSC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533206
- Sponsor's protocol ID
- 20150487-01H
- Status last verified
- Dec 2025
- First submitted
- 6 Jul 2015
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rudmik L, Smith KA, Kilty S. Endoscopic polypectomy in the clinic: a pilot cost-effectiveness analysis. Clin Otolaryngol. 2016 Apr;41(2):110-7. doi: 10.1111/coa.12473. Epub 2016 Feb 4.
PubMed 26053107Kilty SJ. In-clinic endoscopic polypectomy for chronic rhinosinusitis with polyps: a treatment strategy pilot study in ten adults. Clin Otolaryngol. 2015 Jun;40(3):281-4. doi: 10.1111/coa.12372. No abstract available.
PubMed 25581621
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 (EPIC) for Chronic Rhinosinusitis With Polyps: Pilot Study of The EPIC Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02533206
- Acronym / sponsor ID
- 20150487-01H
- Conditions
- Sinusitis, Nasal Polyps
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Aug 2015 (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 sinusitis is one of the most common chronic diseases in North America, with over 5% of the Canadian population affected by the disease. Until now, treatment with surgery has been performed only in the operating room. Recently a smaller surgical procedure that is done in the clinic for some patients with chronic sinusitis with polyps has been found to result in symptom control that appears to be similar to that which occurs with sinus surgery. Performing the smaller clinical procedure has advantages including a shorter recovery time for the patient, a much lower cost to the health care system for the procedure, and a shorter patient wait time for the procedure to be done in comparison to sinus surgery performed in the operating room. To know with greater certainty that the procedure performed in the clinic is as good as the operating room sinus surgery, a large multiple investigator randomised clinical trial has been designed. However, before carrying out that trial, a practice run or internal pilot study of that trial is required to ensure that the trial can recruit patients at the rate that is anticipated and that the procedures to obtain the measurements being used for the larger study are adequate.
Detailed description
For the proposed internal pilot study 20 patients who consent to participate and meet all inclusion criteria and none of the inclusion criteria will be enrolled. The internal pilot study will be carried out at sites located in Ottawa , Winchester, Toronto, Barrie, Sault Saint Marie and London Ontario. A total of 7 investigator-surgeons will participate. Since this is an internal pilot study a sample size was not calculated, rather, the 20 patients enrolled in the internal pilot study will be included as part of the total sample of the definite non-inferiority trial, which has been calculated to be 140 patients. The pilot will recruit 15% of the total sample which is sufficient to achieve the main goal of this pilot i.e. establish the feasibility of the main trial. Eligible participants will be randomly assigned in a 1:1 fashion to either the experimental (endoscopic polypectomy performed in clinic, EPIC) or the control group (functional endoscopic sinus surgery, FESS) . Patients will be allocated to treatment group using web-based central randomization to protect against bias , these data will be used to confirm the design the non-inferiority randomized control trial.
Duration of treatment period For both experimental (endoscopic polypectomy performed in clinic, EPIC) and control (functional endoscopic sinus surgery, FESS) groups, the day the treatment is completed will be considered to be time "0". There is no change to either procedure related to the participant having enrolled into the study. After the treatment day, participants will enter a follow-up period where the final study related evaluation is 90(± 5) days following their procedure.
Frequency and duration of follow up Enrolled participants will be re-evaluated by the investigators after their procedure twice, which is the normal frequency of visits for postoperative care for patients who have undergone surgical treatment for chronic rhinosinusitis with polyps. The first follow-up evaluation at 15 days (± 5 days) following the procedure and the last will occur 90 days (± 5 days) following the treatment. The last follow-up is chosen to be at 90 days given the primary outcome measure of interest is the sinonasal outcome test-22 (SNOT-22) score. Three months after treatment the SNOT-22 does not appear to change substantially with further follow-up. A landmark study completed by Hopkins et al. (2006) with a cohort of over 3000 patients who had undergone endoscopic sinus surgery for chronic sinusitis and who were followed for 36 months demonstrated that the sinonasal outcome test SNOT-22 scores at 3 months following surgery were not different from those measured at 12 or 36 months. Therefore, the 3-month (90 days) follow-up has been specifically chosen for this study given the primary outcome measure being used is also the SNOT-22 score.
Long Term Follow up:
After the second follow up visit, patients will enter a long term follow-up period which will last 5 years. During this period, patients will receive the following questionnaires via mail: SNOT-22, EuroQol (EQ-5D-5L) questionnaire, work productivity and impairment questionnaire (WPAI), Satisfaction Survey and the Individual Health Resource Consumption. These questionnaires will be mailed at 6 months, 1,2,3,4 and 5 years after the procedure. At this time patients will also be asked if they have had additional surgeries for their chronic rhinosinusitis with nasal polyps
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPIC | Experimental | Procedure: Endoscopic Polypectomy Performed in ClinicThe 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. The participant will be discharged home from the clinic following their procedure. |
| FESS | Active comparator | Procedure: Functional Endoscopic Sinus Surgery (FESS)The control intervention is functional endoscopic sinus surgery (FESS), 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 |
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. 21
- 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.
- Must have nasal blockage score greater than or equal to 4 on the sinonasal outcome test SNOT-22 (Appendix 3) at the screening visit.
- 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.
Key exclusion criteria (21 listed)
- Women who are pregnant or breast feeding
- 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 Performed in ClinicAlso: EPICEndoscopic polypectomy performed in clinic under local and topical anesthesia | Procedure or surgery | EPIC |
| Functional Endoscopic Sinus Surgery (FESS)Also: FESSFunctional Endoscopic Sinus Surgery | Procedure or surgery | FESS |
Primary outcome
Rate of recruitment
Time frame: One year
Number of patients recruited in one year
2 secondary outcomes
Arm cross-over
Time frame: One year
Loss to follow up
Time frame: Evaluated at 6 months after intervention
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.
- Background: PubMed 26053107Rudmik L, Smith KA, Kilty S. Endoscopic polypectomy in the clinic: a pilot cost-effectiveness analysis. Clin Otolaryngol. 2016 Apr;41(2):110-7. doi: 10.1111/coa.12473. Epub 2016 Feb 4.
- Background: PubMed 25581621Kilty SJ. In-clinic endoscopic polypectomy for chronic rhinosinusitis with polyps: a treatment strategy pilot study in ten adults. Clin Otolaryngol. 2015 Jun;40(3):281-4. doi: 10.1111/coa.12372. No abstract available.
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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. This study is not recruiting at the moment.
Shaun Kilty, MD, FRCSC principal investigator
Ottawa Hospital Research Institute
5 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 Performed in Clinic and Functional Endoscopic Sinus Surgery (FESS) in people with Sinusitis and Nasal Polyps, run by Ottawa Hospital Research Institute at 5 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: under way, not looking for participants, 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 5 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment (time frame: One year). 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 NCT02533206, which also lists 2 linked publications.
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.