NCT01455948

Brief Summary

The economic, patient related outcome, and effectiveness of balloon sinuplasty in the treatment of CRS patients with frontal and other sinus disease in the Canadian healthcare environment is not known at this time. This study will evaluate the impact of balloon sinuplasty and traditional FESS treatment on CRS patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

October 11, 2011

Last Update Submit

July 10, 2024

Conditions

Chronic Rhinosinusitis

Keywords

sinusitischronicFunctional endoscopic sinus surgeryballoon sinuplasty

Outcome Measures

Primary Outcomes (1)

  • The direct and indirect costs of treatment of frontal and other sinus disease with Functional Endoscopic Sinus Surgery or balloon sinuplasty.

    6 months

Secondary Outcomes (2)

  • Health outcome of patients in the two treatment groups.

    6 months

  • Effectiveness of the two treatment groups in relieving symptomology of CRS.

    6 months

Study Arms (2)

Balloon Sinuplasty™ System

ACTIVE COMPARATOR
Device: Relieva Balloon Sinuplasty™ System

Functional Endoscopic Sinus Surgery

ACTIVE COMPARATOR
Procedure: Functional Endoscopic Sinus Surgery

Interventions

Relieva Balloon Sinuplasty™ SystemDEVICE

Catheter-based devices used to dilate blocked paranasal sinus ostia (openings).

Balloon Sinuplasty™ System
Functional Endoscopic Sinus SurgeryPROCEDURE

Specialized probes are used to cannulate closed ostia (openings), and small forceps are used to resect periostial bone and tissue to enlarge the sinus ostia.

Functional Endoscopic Sinus Surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented diagnosis of unilateral or bilateral Chronic Rhinosinusitis based on the European Position Paper on Rhinosinusitis and Nasal Polyps (2) with at least frontal and maxillary sinus involvement
  • Documented failed medical treatment of CRS
  • Eighteen (18) to sixty-five (65) years of age
  • Employed in full time position or equivalent
  • Planned FESS for treatment of CRS
  • Must have an American Society of Anesthesiologists physical status of P3 classification or less
  • Able to provide informed consent by signing the informed consent document at the screening visit prior to any study activities
  • Able to read and understand English

You may not qualify if:

  • Previous sinonasal surgery
  • Pregnant
  • Cystic Fibrosis
  • Diagnosed immotile cilia syndrome
  • Samter's Triad
  • Diagnosed immunodeficiency syndrome
  • Diagnosed fungal sinusitis
  • Concurrent septoplasty or turbinate surgery
  • Diagnosed recurrent acute sinusitis
  • Current smoker
  • Presence of grade 2 or greater nasal polyps
  • Sinonasal tumors or obstructive lesions
  • History of substance or alcohol abuse within the past 12 months
  • Investigator's opinion that the subject should not be in the study such as any conditions that could compromise the wellbeing of the patient or integrity of the study or prevent the patient from meeting or performing study requirements
  • Participation in a research study 30 days prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

St. Joseph's Health Centre

London, Ontario, N6A 4V2, Canada

Location

Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Trillium Health Centre

Toronto, Ontario, L5C 4E9, Canada

Location

Toronto East General

Toronto, Ontario, M4C 3E7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

St. Joseph's Health Centre

Toronto, Ontario, M6R 1B5, Canada

Location

MeSH Terms

Conditions

SinusitisBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Ian Witterick, MD, MSc

    Mount Sinai Hospital, Toronto, Ontario, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2011

First Posted

October 20, 2011

Study Start

February 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

July 11, 2024

Record last verified: 2024-07

Locations

CA(8)