CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
FESS instruments with or without balloon treatment +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00939393
NCT00939393N/ACompleted

ESS Performed in Operating Room Versus Clinician's Office

Integra LifeSciences Corporation·interventional·Posted Jul 15, 2009·Updated Jul 12, 2024

In Brief

A clinical study evaluating FESS instruments with or without balloon treatment and Balloon Sinuplasty for Chronic Sinusitis. Completed, enrolled 72 participants across 1 site.

Detailed Summary

Endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAcclarent

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 15, 2009
Enrollment StartApr 1, 2008
Primary CompletionJun 1, 2009
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.0 years ago

Interventions

FESS instruments with or without balloon treatmentdevice

Intervention with metal instruments with or without balloon treatment

Balloon Sinuplastydevice

Balloon dilatation of sinuses