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Sponsored by: |
Acclarent |
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Information provided by: | Acclarent |
ClinicalTrials.gov Identifier: | NCT00939393 |
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 enabling 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.
Condition | Intervention |
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Chronic Sinusitis |
Device: FESS instruments Device: Balloon Sinuplasty |
Study Type: | Interventional |
Study Design: | Health Services Research, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | ESS Performed in Operating Room Versus Clinician's Office |
Estimated Enrollment: | 100 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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FESS: Active Comparator
Functional Endoscopy Sinus Surgery
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Device: FESS instruments
Intervention with metal instruments
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Balloon sinuplasty: Active Comparator
Balloon Sinuplasty using Acclarent devices
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Device: Balloon Sinuplasty
Balloon dilatation of sinuses
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With the recent introduction of minimally invasive balloon catheter dilation technology by Acclarent, Inc., several physicians have begun to explore the possible application of balloon dilatation in the office setting. Leveraging balloon sinuplasty devices as an enabling technology, tremendous cost-saving benefits would be achieved if the OR procedures under general anesthesia could be migrated into the office setting employing only local anesthesia. However, while physicians have expressed great interest in this potential office migration, there is no mechanism currently in place to reimburse office clinics for their corresponding technical fees. In contrast, physician professional fees for these procedures are the same no matter what the site of care setting. This study aims to collect comprehensive operative and post-operative cost data across all settings, studying total resource absorption for procedures able to be performed in the physician office relative to the traditional OR setting. This resultant cost savings will provide the basis for applying for non-facility practice expense RVUs for endoscopic sinus surgery performed in the office setting. Additionally, the study is also evaluating the safety and efficacy of balloon sinuplasty in the office setting.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marcia A. Wachna, BN, RAC | 650-687-5888 | marcia.wachna@acclarent.com |
Contact: Sandra A. Schlachter | 650-687-5888 | sandraschl@sbcglobal.net |
United States, Ohio | |
Director, Cleveland Nasal Sinus & Sleep Center | Recruiting |
Cleveland, Ohio, United States, 44124 | |
Contact: Howard L. Levine, MD 440-684-9980 hlevine@clevelandnasalsinus.com | |
Contact: Marcia A Wachna, BN 650-687-5888 marcia.wachna@acclarent.com | |
Principal Investigator: Howard L. Levine, MD |
Principal Investigator: | Howard L. Levine, MD | Director, Cleveland Nasal Sinus & Sleep Center |
Responsible Party: | Acclarent, Inc. ( Marcia Wachna, Director of Clinical Research ) |
Study ID Numbers: | CPR 005002 |
Study First Received: | July 14, 2009 |
Last Updated: | July 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00939393 History of Changes |
Health Authority: | United States: Institutional Review Board |
endoscopic sinus surgery balloon catheters FESS |
Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Sinusitis |
Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Paranasal Sinus Diseases Sinusitis Nose Diseases |