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In-Office Clinical Trial (ORIOS)
This study is currently recruiting participants.
Verified by Acclarent, July 2009
First Received: July 14, 2009   Last Updated: July 17, 2009   History of Changes
Sponsored by: Acclarent
Information provided by: Acclarent
ClinicalTrials.gov Identifier: NCT00939393
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Comparison of the total cost of ESS (with balloon) in office vs. ESS (with or without balloon) in the OR, including operative costs, and post-operative costs [ Time Frame: June 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and effectiveness of ESS (with balloon) in office vs. ESS (with or without balloon) in the OR, by assessments of patency, Kennedy-Lund endoscopic scores, revisions, sinus infections, Lund-MacKay CT scores, days off work and quality of life [ Time Frame: June 2010 ] [ Designated as safety issue: Yes ]

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
FESS: Active Comparator
Functional Endoscopy Sinus Surgery
Device: FESS instruments
Intervention with metal instruments
Balloon sinuplasty: Active Comparator
Balloon Sinuplasty using Acclarent devices
Device: Balloon Sinuplasty
Balloon dilatation of sinuses

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. Sampter'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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939393

Contacts
Contact: Marcia A. Wachna, BN, RAC 650-687-5888 marcia.wachna@acclarent.com
Contact: Sandra A. Schlachter 650-687-5888 sandraschl@sbcglobal.net

Locations
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            
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Howard L. Levine, MD Director, Cleveland Nasal Sinus & Sleep Center
  More Information

No publications provided

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

Keywords provided by Acclarent:
endoscopic sinus surgery
balloon catheters
FESS

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Sinusitis

Additional relevant MeSH terms:
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Paranasal Sinus Diseases
Sinusitis
Nose Diseases

ClinicalTrials.gov processed this record on September 11, 2009