Chronic Sinusitis
Conditions
Keywords
sinusitis, rhinitis, sinus surgery, maxillary, ethmoid, sphenoid, frontal, FESS, sinuplasty
Brief summary
A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.
Detailed description
Sinusitis is a common healthcare problem that significantly reduces quality of life for people around the world. Patients suffer from headache, facial discomfort, nasal congestion, nasal drainage, loss of the sense of smell and malaise. Sinusitis is responsible for major healthcare expenditure and loss of workplace productivity. The rationale of this study is to collect data on the effectiveness and safety of balloon dilation of the Frontal, Maxillary and Sphenoid sinuses by treating patients and observing them for a six month period of time following the procedure. Six month follow-up data is important to demonstrate the effectiveness of balloon catheter dilation.
Interventions
DEVICESinuplasty
Sponsors
Acclarent
Integra LifeSciences Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 4. Planned endoscopic sinus surgery (recommended by PI, consented to by patient)
Exclusion criteria
1. Extensive sinonasal polyps 2. Extensive previous sinonasal surgery 3. Extensive sinonasal osteoneogenesis 4. Cystic fibrosis 5. Sampter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis) 6. Sinonasal tumors or obstructive lesions 7. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium 8. Ciliary dysfunction 9. Pregnant females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Sinuses With Patency of Sinus Ostium After Sinuplasty | 24 weeks | Patency of sinus ostium after sinuplasty will be determined by nasal endoscopic examination. The investigator will make a clinical judgment as to whether or not this has been achieved. |
| Number of Participants With Adverse Events Following Sinuplasty Procedure | 24 weeks | Adverse event rate at 24 weeks: comprised of all observed peri-operative adverse events which were recorded on dedicated CRFs and any observed or patient-reported post-operative adverse events will be similarly recorded (through 24 week follow-up). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Relief of Sinus Symptoms | Week 24 | To gain general insight into the ability of balloon catheter sinus ostial dilation to relieve sinus symptoms, scores from the pre-operative SNOT-20 evaluations were compared to scores from the post-procedure SNOT-20 evaluations at 24 weeks following the procedure. The number of participants who showed aggregate symptom relief are recorded here as having been successfully treated. |
Participant flow
Recruitment details
Recruited from 3/2005 to 12/2005 in physician practice
Participants by arm
| Arm | Count |
|---|---|
| Balloon Dilation of Sinus Ostia | 115 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 6 |
Baseline characteristics
| Characteristic | Balloon Dilation of Sinus Ostia |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 102 Participants |
| Age, Continuous | 47.8 years STANDARD_DEVIATION 12.59 |
| Region of Enrollment United States | 115 participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 109 |
| serious Total, serious adverse events | 0 / 109 |
Outcome results
Primary
Number of Participants With Adverse Events Following Sinuplasty Procedure
Adverse event rate at 24 weeks: comprised of all observed peri-operative adverse events which were recorded on dedicated CRFs and any observed or patient-reported post-operative adverse events will be similarly recorded (through 24 week follow-up).
Time frame: 24 weeks
Population: Analysis per protocol; based on subjects not lost to follow-up at 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Dilation of Sinus Ostia | Number of Participants With Adverse Events Following Sinuplasty Procedure | 9 Participants |
Primary
Number of Sinuses With Patency of Sinus Ostium After Sinuplasty
Patency of sinus ostium after sinuplasty will be determined by nasal endoscopic examination. The investigator will make a clinical judgment as to whether or not this has been achieved.
Time frame: 24 weeks
Population: Analysis per Protocol; based on all sinuses of subjects not lost to follow-up at 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Dilation of Sinus Ostia | Number of Sinuses With Patency of Sinus Ostium After Sinuplasty | 247 Sinuses |
Secondary
Number of Participants Experiencing Relief of Sinus Symptoms
To gain general insight into the ability of balloon catheter sinus ostial dilation to relieve sinus symptoms, scores from the pre-operative SNOT-20 evaluations were compared to scores from the post-procedure SNOT-20 evaluations at 24 weeks following the procedure. The number of participants who showed aggregate symptom relief are recorded here as having been successfully treated.
Time frame: Week 24
Population: All patients treated per protocol; includes all subjects not lost to follow-up at 24 weeks and who completed symptom questionnaire
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Dilation of Sinus Ostia | Number of Participants Experiencing Relief of Sinus Symptoms | 80 Participants |