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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sinonasal Outcome Test-22 (SNOT-22)
Secondary outcome measures
Adverse Events
EQ-5D-5L
Iowa Satisfaction with Anesthesia Scale (ISAS)
+3 moreOther outcome measures
Lund-Kennedy Endoscopic Scoring Scale
Visual Analogue Scale (VAS) for satisfaction with assigned procedure
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),
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Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,348 Previous Clinical Trials
26,455,445 Total Patients Enrolled
MedtronicIndustry Sponsor
608 Previous Clinical Trials
828,545 Total Patients Enrolled
Ottawa Hospital Research InstituteLead Sponsor
563 Previous Clinical Trials
2,787,577 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still an opportunity to participate in this research?
"Affirmative. Online records from clinicaltrials.gov indicate that this medical trial is presently recruiting patients, with the initial posting occurring on April 11th 2017 and the last update taking place September 20th 2022. 140 subjects are needed across 4 separate clinics."
Answered by AI
How many patients is the clinical trial recruiting for participation?
"Affirmative. According to the info available on clinicaltrials.gov, this research is currently looking for participants - with 140 individuals sought from 4 sites. The trial was originally posted in April 2017 and its most recent update occurred on September 20th 2022."
Answered by AI
To what capacity is this experiment being implemented in various locations?
"Presently, this trial is being conducted at 4 distinct sites: Ottawa, London, Montréal and other nearby locales. To limit the amount of travel required for participants, it's best to select the closest location available."
Answered by AI
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