In-Office Clinical Trial (ORIOS)
This study has been completed.
Sponsor:
Acclarent
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT00939393
First received: July 14, 2009
Last updated: August 31, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- Age 18 years and greater
- Both male and female patients eligible
- 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)
- Planned endoscopic sinus surgery (recommended by investigator, consented to by patient)
Exclusion Criteria:
- Cystic fibrosis
- Sampter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
- Sinonasal tumors or obstructive lesions
- History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
- Ciliary dysfunction
- Pregnant females
Contacts and Locations 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 May 23, 2013