Chronic Rhinosinusitis, Recurrent Acute Rhinosinusitis
Conditions
Brief summary
This study evaluates long-term safety and effectiveness of primary sinus surgery in a real-world population of adults with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS). This post-market study will evaluate sinus surgery performed using commercially available sinus instrumentation (e.g. sinus balloon catheters, powered microdebriders, manual instruments).
Interventions
None listed
Sponsors
Acclarent
Integra LifeSciences Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years or minimum adult age as required by local regulations * The subject has a planned primary sinus surgery, which includes either traditional transnasal endoscopic sinus surgery (ESS), balloon sinus dilation (BSD) or a hybrid procedure * Subjects diagnosed by ENT surgeon with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) per AAO-HNS or EPOS adult sinusitis clinical practice guidelines * The subject has been informed of the nature of the registry and has consented to participate and authorized the collection and release of medical information by signing a consent form * Subject is able to read and understand local language
Exclusion criteria
* Prior sinus surgery. Septoplasty, Nasal Polypectomy, Septorhinoplasty, Nasal Valve and Turbinate Reduction surgeries are not exclusions * Planned surgery of any of the following : orbital decompression, skull base, neoplasm, lacrimal, UPPP, aesthetic surgery, Potts Puffy tumor, Draf III * Planned external approaches (i.e. not trans-nasal) * Planned off-label usage of balloon sinus dilation products. * Balloon sinus dilation performed with a non-Acclarent balloon product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Completing Follow-Up Visits | 2 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Balloon Sinus Dilation Subjects who underwent a balloon sinus dilation procedure | 140 |
| Endoscopic Sinus Surgery (ESS) Subjects who underwent a transnasal endoscopic sinus surgery | 67 |
| Hybrid Subjects who underwent a procedure with balloon sinus dilation and transnasal endoscopic sinus surgery. | 45 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Study was cancelled | 140 | 67 | 45 |
Baseline characteristics
| Characteristic | Balloon Sinus Dilation | Endoscopic Sinus Surgery (ESS) | Hybrid | Total |
|---|---|---|---|---|
| Age, Continuous | 47.1 Years STANDARD_DEVIATION 14.83 | 43.3 Years STANDARD_DEVIATION 14.42 | 43.8 Years STANDARD_DEVIATION 18.02 | 45.5 Years STANDARD_DEVIATION 15.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 12 Participants | 9 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 127 Participants | 55 Participants | 36 Participants | 218 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 16 Participants | 0 Participants | 2 Participants | 18 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 0 Participants | 5 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 118 Participants | 64 Participants | 36 Participants | 218 Participants |
| Sex: Female, Male Female | 77 Participants | 39 Participants | 29 Participants | 145 Participants |
| Sex: Female, Male Male | 63 Participants | 28 Participants | 16 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 140 | 4 / 67 | 0 / 45 |
| serious Total, serious adverse events | 1 / 140 | 1 / 67 | 0 / 45 |
Outcome results
Primary
Number of Participants Completing Follow-Up Visits
Time frame: 2 years
Population: Due to early cancellation of the study data for this endpoint were not collected.