In-Office Clinical Trial (ORIOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT00939393
First received: July 14, 2009
Last updated: August 31, 2012
Last verified: January 2012
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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 ]

Enrollment: 72
Study Start Date: April 2008
Study Completion Date: February 2012
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FESS
Functional Endoscopy Sinus Surgery
Device: FESS instruments
Intervention with metal instruments
Active Comparator: Balloon sinuplasty
Balloon Sinuplasty using Acclarent devices
Device: Balloon Sinuplasty
Balloon dilatation of sinuses

  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

Locations
United States, Ohio
Cleveland, Ohio, United States
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: xxx x xxxx xxx
  More Information

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT00939393     History of Changes
Other Study ID Numbers: CPR 005002
Study First Received: July 14, 2009
Last Updated: August 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014