Balloon Sinus Dilation In Office or OR

Chronic Sinusitis Clinical Trial

— ORIOS  

Official title:

ESS Performed in Operating Room Versus Clinician's Office

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939393
• Other study ID #: CPR005002
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: September 21, 2017
• Start date: April 1, 2008
• Est. completion date: July 1, 2010

Study information

• Verified date: September 2017
• Source: Acclarent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices.

Description:

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 1, 2010
• Est. primary completion date: June 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. Samter'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

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

Intervention

Device:
• FESS instruments with or without balloon treatment
Intervention with metal instruments with or without balloon treatment
• Balloon Sinuplasty
Balloon dilatation of sinuses

Locations

Country	Name	City	State
United States	Rockside Road Surgery Center	Independence	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Acclarent

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline	The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.	24 weeks
Secondary	Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks]	The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden.	24 weeks
Secondary	Proportion of Participants Rating Procedure as Tolerable (IO Only)	Participants evaluated the tolerability of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'not tolerated' and '5' represented 'highly tolerable'. Scores of 3 through 5 were consdered tolerable ratings. The endpoint reports the proportion of participants rating the procedure as tolerable.	Day 0
Secondary	Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only)	Participants evaluated the per-procedural pain of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'no pain' and '5' represented 'intense pain'. Scores of 0 through 2 were considered ratings of no pain or pain of low intensity. The endpoint reports the proportion of participants reporting no pain or pain of low intensity.	Day 0
Secondary	Mean Number of Debridements Per Participant (IO Only)	A debridement is a procedure to remove post-surgical crusts, mucus, and fibrin from obstructed nasal and sinus cavities after functional endoscopic sinus surgery. Each physician visit in which a debridement was performed was counted as one debridement.	52 weeks
Secondary	Proportion of Participants With Revisions (IO Only)	After sinus surgery, the patient may require a subsequent sinus procedure (a revision procedure) to address recurrence of disease. These revision procedures are assessed in this outcome measure.	52 weeks
Secondary	Proportion of Participants With Post-operative Sinus Infections	Investigators reported the sinus infections as secondary to chronic rhinosinusitis (CRS) or other pre-existing conditions such as allergies. The rates of these sinus infections are consistent with the disease burden of the subjects and consistent with post procedure symptomatology associated with endoscopic sinus surgery (ESS).	52 weeks
Secondary	Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline	The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.	1 week
Secondary	Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline	The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.	4 weeks
Secondary	Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline	The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.	52 weeks