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In-Clinic Endoscopic Polypectomy for Nasal Polyps

N/A
Recruiting
Led By Shaun Kilty, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have an American Society of Anesthesiologists physical status PS3 classification or less
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 not have
Patients with hyperplastic polyps or polyps large enough that they result in external nasal deformity
History of any surgical procedure that prevents the ability to accurately grade the nasal polyps
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effectiveness of a new in-clinic sinus surgery procedure to the current standard operating room procedure.

Who is the study for?
Adults over 18 with chronic sinusitis and nasal polyps, who've tried medical therapy without success. They must be in stable health (not severely ill), not pregnant or breastfeeding, and able to consent. Excluded are those with certain nasal conditions, immune disorders, drug allergies, or unable to follow the study protocol.
What is being tested?
The trial is testing if removing nasal polyps in a clinic setting (EPIC) is as effective as traditional surgery under general anesthesia in an operating room for treating chronic sinusitis symptoms. It also compares costs and recovery times between these two methods.
What are the potential side effects?
Possible side effects include discomfort from local/topical anesthesia used during EPIC, bleeding after polyp removal, infection risks similar to any minor surgical procedure, and reactions specific to the medications used during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My health is good enough for surgery according to the ASA classification.
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I have moderate to severe nasal polyps in both nostrils.
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I often have a blocked nose, as per my recent test results.
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I am 18 years old or older.
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I have chronic sinusitis with polyps and need surgery after trying other treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have nasal polyps that are causing my nose to change shape.
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I've had surgery that affects the grading of nasal polyps.
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I have a condition that weakens my immune system.
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I have been diagnosed with allergic fungal sinusitis.
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I cannot take oral corticosteroids due to health reasons.
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I have a history of Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis.
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I am not fit for surgery under general anesthesia.
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I cannot have procedures done while awake.
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I have been diagnosed with AERD.
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I experience significant facial pain or pressure.
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I have been diagnosed with cystic fibrosis.
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I am not pregnant or breastfeeding.
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I have major issues with the structure of my mouth, like an unrepaired cleft palate.
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I need surgery to correct a deviated septum for further nasal procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
EQ-5D-5L
Iowa Satisfaction with Anesthesia Scale (ISAS)
Participant Health Resource Consumption Survey
+1 more
Other study objectives
Lund-Kennedy Endoscopic Scoring Scale
Visual Analogue Scale (VAS) for satisfaction with assigned procedure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Endoscopic polypectomy in clinic (EPIC)Experimental Treatment2 Interventions
Patients assigned to this arm of the study will undergo the In Clinic Polypectomy Performed in Clinic
Group II: Endoscopic Sinus Surgery (ESS)Active Control2 Interventions
Patients assigned to this arm will undergo endoscopic sinus surgery (ESS),

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,517,933 Total Patients Enrolled
MedtronicIndustry Sponsor
618 Previous Clinical Trials
763,873 Total Patients Enrolled
Ottawa Hospital Research InstituteLead Sponsor
575 Previous Clinical Trials
3,094,743 Total Patients Enrolled

Media Library

Endoscopic polypectomy in clinic (EPIC) Clinical Trial Eligibility Overview. Trial Name: NCT02975310 — N/A
Nasal Polyp Size Research Study Groups: Endoscopic Sinus Surgery (ESS), Endoscopic polypectomy in clinic (EPIC)
Nasal Polyp Size Clinical Trial 2023: Endoscopic polypectomy in clinic (EPIC) Highlights & Side Effects. Trial Name: NCT02975310 — N/A
Endoscopic polypectomy in clinic (EPIC) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02975310 — N/A
~16 spots leftby Nov 2025
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