Balloon Sinus Dilation In Office or OR

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-01

Study Completion Date

2010-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Sinusitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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FESS in OR with or without balloons

Functional Endoscopy Sinus Surgery

Group Type ACTIVE_COMPARATOR

FESS instruments with or without balloon treatment

Intervention Type DEVICE

Intervention with metal instruments with or without balloon treatment

Balloon sinuplasty in physician office

Balloon Sinuplasty in physician office using Acclarent devices

Group Type ACTIVE_COMPARATOR

Balloon Sinuplasty

Intervention Type DEVICE

Balloon dilatation of sinuses

Interventions

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FESS instruments with or without balloon treatment

Intervention with metal instruments with or without balloon treatment

Intervention Type DEVICE

Balloon Sinuplasty

Balloon dilatation of sinuses

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No