N/A N=72 Health Services Research

Balloon Sinus Dilation In Office or OR

Chronic Sinusitis

Bottom Line

View on ClinicalTrials.gov: NCT00939393 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcome: Primary: Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline — -1.25; -1.35 scores on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FESS instruments with or without balloon treatment (Device); Balloon Sinuplasty (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Integra LifeSciences Corporation
Primary completion: Jun 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline	-1.25; -1.35	—
SECONDARY Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks]	-3.83; -5.65	—
SECONDARY Proportion of Participants Rating Procedure as Tolerable (IO Only)	27	—
SECONDARY Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only)	24	—
SECONDARY Mean Number of Debridements Per Participant (IO Only)	0.42	—
SECONDARY Proportion of Participants With Revisions (IO Only)	1	—
SECONDARY Proportion of Participants With Post-operative Sinus Infections	13; 12	—
SECONDARY Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline	-0.98; -0.71	—
SECONDARY Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline	-1.32; -1.21	—
SECONDARY Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline	-1.43; -1.10	—

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.

Eligibility 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
Samter'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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00939393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.