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Balloon Sinus Dilation In Office or OR | Clinical Trials | Clareo Health

COMPLETEDNA

Balloon Sinus Dilation In Office or OR

ESS Performed in Operating Room Versus Clinician's Office

NCT00939393•Integra LifeSciences Corporation

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.

Detailed Description

In this study, 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 the balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices. Both primary treatment of sinusitis as well as revision of previously treated sinuses will be allowed. Resource absorption will be evaluated for both venues.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 years and greater
•2. Both male and female patients eligible
•3. Diagnosis of chronic sinusitis that is not responsive to medical management (\> 12 weeks of symptoms and failed at least 3 to 6 weeks of appropriate antibiotic therapy as evidenced by presence of disease on CT scan)
•4. Planned endoscopic sinus surgery (recommended by investigator, consented to by patient)

Exclusion Criteria

•1. Cystic fibrosis
•2. Samter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
•3. Sinonasal tumors or obstructive lesions
•4. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
•5. Ciliary dysfunction
•6. Pregnant females

Locations (1)

Rockside Road Surgery Center

Independence, Ohio, United States

Key Dates

Start Date

April 1, 2008

Primary Completion Date

June 1, 2009

Completion Date

July 1, 2010

Last Updated

July 12, 2024

Enrollment

ACTUAL participants

Conditions

Chronic Sinusitis

Interventions

FESS instruments with or without balloon treatment

DEVICE

Balloon Sinuplasty

DEVICE

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UNKNOWN

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Balloon Sinus Dilation In Office or OR

Inclusion Criteria

Exclusion Criteria

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