Balloon Sinus Dilation In Office or OR (ORIOS)

ESS Performed in Operating Room Versus Clinician's Office

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.

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis
• Intervention / Treatment: Device: FESS instruments with or without balloon treatment; Device: Balloon Sinuplasty

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Independence, Ohio, United States, 44131
      • Rockside Road Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FESS in OR with or without balloons; Functional Endoscopy Sinus Surgery	Device: FESS instruments with or without balloon treatment; Intervention with metal instruments with or without balloon treatment
Active Comparator: Balloon sinuplasty in physician office; Balloon Sinuplasty in physician office using Acclarent devices	Device: Balloon Sinuplasty; Balloon dilatation of sinuses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Acclarent
• Investigators: Principal Investigator: Howard Levine, MD, Rockside Road Surgery Center Independence, OH

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: July 14, 2009
• First Submitted That Met QC Criteria: July 14, 2009
• First Posted (Estimate): July 15, 2009

Study Record Updates

• Last Update Posted (Actual): October 23, 2017
• Last Update Submitted That Met QC Criteria: September 21, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: CPR005002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes