Optimization and Refinement of Technique in In-Office Sinus Dilation 2

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-07-31

Brief Summary

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A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.

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Detailed Description

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Conditions

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Sinusitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Balloon catheter device

Dilation of sinuses using Relieva Balloon Sinuplasty System

Relieva Balloon Sinuplasty System

Intervention Type DEVICE

Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis

Interventions

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Relieva Balloon Sinuplasty System

Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male/Female, 18 year or older
* Diagnosis of Chronic Rhinosinusitis
* Planned Endoscopic Sinus surgery

Exclusion Criteria

* Cystic Fibrosis
* Severe Polyposis
* Sinonasal tumors
* History of facial trauma precluding access to sinus ostium
* Ciliary Disfunction
* Planned non-sinus surgery (such as rhinoplasty, septoplasty, etc.)
* Pregnant or lactating female
* Inability to tolerate an awake procedure
* Participation in another investigational clinical study involving treatment for chronic rhinosinusitis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No