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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 belowSelect...
My health is good enough for surgery according to the ASA classification.
Select...
I have moderate to severe nasal polyps in both nostrils.
Select...
I often have a blocked nose, as per my recent test results.
Select...
I am 18 years old or older.
Select...
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:Select...
I have nasal polyps that are causing my nose to change shape.
Select...
I've had surgery that affects the grading of nasal polyps.
Select...
I have a condition that weakens my immune system.
Select...
I have been diagnosed with allergic fungal sinusitis.
Select...
I cannot take oral corticosteroids due to health reasons.
Select...
I have a history of Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis.
Select...
I am not fit for surgery under general anesthesia.
Select...
I cannot have procedures done while awake.
Select...
I have been diagnosed with AERD.
Select...
I experience significant facial pain or pressure.
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I have been diagnosed with cystic fibrosis.
Select...
I am not pregnant or breastfeeding.
Select...
I have major issues with the structure of my mouth, like an unrepaired cleft palate.
Select...
I need surgery to correct a deviated septum for further nasal procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
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 moreOther 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
1,392 Previous Clinical Trials
26,529,305 Total Patients Enrolled
MedtronicIndustry Sponsor
619 Previous Clinical Trials
763,948 Total Patients Enrolled
Ottawa Hospital Research InstituteLead Sponsor
577 Previous Clinical Trials
3,139,808 Total Patients Enrolled
1 Trials studying Nasal Polyps
20 Patients Enrolled for Nasal Polyps
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with allergic fungal sinusitis.I have nasal polyps that are causing my nose to change shape.I've had surgery that affects the grading of nasal polyps.I have a condition that weakens my immune system.My health is good enough for surgery according to the ASA classification.You are allergic to or cannot use certain numbing medications or nasal sprays.I have moderate to severe nasal polyps in both nostrils.I often have a blocked nose, as per my recent test results.I cannot take oral corticosteroids due to health reasons.I have a history of Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis.I am not fit for surgery under general anesthesia.I cannot have procedures done while awake.I have been diagnosed with AERD.I am 18 years old or older.I experience significant facial pain or pressure.I have chronic sinusitis with polyps and need surgery after trying other treatments.I understand the study's purpose and procedures and agree to participate.I have been diagnosed with cystic fibrosis.I am not pregnant or breastfeeding.I have major issues with the structure of my mouth, like an unrepaired cleft palate.I need surgery to correct a deviated septum for further nasal procedures.My asthma or COPD has been stable with no flare-ups in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Endoscopic Sinus Surgery (ESS)
- Group 2: Endoscopic polypectomy in clinic (EPIC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.