Clinical trial NCT00939393: Balloon Sinus Dilation In Office or OR
Official title: ESS Performed in Operating Room Versus Clinician's Office
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sinusitis
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2009-07-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility 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. 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

Primary outcomes:
measure: Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline
timeFrame: 24 weeks
Secondary outcomes:
measure: Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks]
timeFrame: 24 weeks
measure: Proportion of Participants Rating Procedure as Tolerable (IO Only)
timeFrame: Day 0
measure: Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only)
timeFrame: Day 0
measure: Mean Number of Debridements Per Participant (IO Only)
timeFrame: 52 weeks
measure: Proportion of Participants With Revisions (IO Only)
timeFrame: 52 weeks
measure: Proportion of Participants With Post-operative Sinus Infections
timeFrame: 52 weeks
measure: Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline
timeFrame: 1 week
measure: Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline
timeFrame: 4 weeks
measure: Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Independence
country: United States
facility: Rockside Road Surgery Center
state: Ohio
Study officials:
affiliation: Rockside Road Surgery Center Independence, OH
name: Howard Levine, MD
role: PRINCIPAL_INVESTIGATOR
References: