Clinical Trials Directory

Trials / Terminated

TerminatedNCT01455948

Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis

Canadian Health Economics, Health Outcome, and Effectiveness Comparison of Treatment of the Frontal Sinus Ostium and Recess and Other Sinuses With Functional Endoscopic Sinus Surgery (FESS) or Balloon Sinuplasty in Patients With Chronic Sinusitis (CRS)

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Integra LifeSciences Corporation · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICERelieva Balloon Sinuplasty™ SystemCatheter-based devices used to dilate blocked paranasal sinus ostia (openings).
PROCEDUREFunctional Endoscopic Sinus SurgerySpecialized probes are used to cannulate closed ostia (openings), and small forceps are used to resect periostial bone and tissue to enlarge the sinus ostia.

Timeline

Start date
2012-02-01
Primary completion
2012-11-01
Completion
2012-11-01
First posted
2011-10-20
Last updated
2024-07-11

Locations

8 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT01455948. Inclusion in this directory is not an endorsement.