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Pilot Study of The EPIC Trial

NCT02533206 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-30

No results posted yet for this study

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. 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.

Conditions

  • Sinusitis
  • Nasal Polyps

Interventions

PROCEDURE

Endoscopic Polypectomy Performed in Clinic

Endoscopic polypectomy performed in clinic under local and topical anesthesia

PROCEDURE

Functional Endoscopic Sinus Surgery (FESS)

Functional Endoscopic Sinus Surgery

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Shaun Kilty, MD, FRCSC · The Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2022-12-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02533206 on ClinicalTrials.gov