Sinusitis
Conditions
Brief summary
A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.
Interventions
DEVICERelieva Balloon Sinuplasty System
Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis
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
* Male/Female, 18 year or older * Diagnosis of Chronic Rhinosinusitis * Planned Endoscopic Sinus surgery
Exclusion criteria
* Cystic Fibrosis * Severe Polyposis * Sinonasal tumors * History of facial trauma precluding access to sinus ostium * Ciliary Disfunction * Planned non-sinus surgery (such as rhinoplasty, septoplasty, etc.) * Pregnant or lactating female * Inability to tolerate an awake procedure * Participation in another investigational clinical study involving treatment for chronic rhinosinusitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intra-patient Change in SNOT-20 Score | Baseline and 24 weeks | Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data. 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 and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the 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. |
| Mean Intra-patient Change in Lund-Mackay CT Scan Score | Baseline and 24 weeks | Change in Lund-Mackay CT score for paired baseline and 24 week data. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Tolerability | Day 0 (Day of Procedure) | Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable. |
| Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary | Day 0 (Day of Procedure) | Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary |
| Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events. | Day 0 (Day of Procedure) | Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events. |
| Mean Number of Days to Return to Normal Activities | 2 weeks | Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living |
Countries
United States
Participant flow
Pre-assignment details
The lead-in cohort (N=36) consisted of each investigator's first cases where all targeted sinuses were successfully dilated (minimum of 3 cases) with the exception of 4 investigators who participated in the prior ORIOS study.
Participants by arm
| Arm | Count |
|---|---|
| Balloon Catheter Device Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for sinus dilation | 203 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 18 |
Baseline characteristics
| Characteristic | Balloon Catheter Device |
|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 15.4 |
| Race/Ethnicity, Customized Asian | 5 participants |
| Race/Ethnicity, Customized Black or African | 22 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 22 participants |
| Race/Ethnicity, Customized Native Hawaiian / Other Pacific Islander | 1 participants |
| Race/Ethnicity, Customized North American Indian or Inuit | 2 participants |
| Race/Ethnicity, Customized Other (not specified) | 6 participants |
| Race/Ethnicity, Customized White/Caucasian | 145 participants |
| Region of Enrollment United States | 203 participants |
| Sex: Female, Male Female | 108 Participants |
| Sex: Female, Male Male | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 44 / 203 |
| serious Total, serious adverse events | 1 / 203 |
Outcome results
Primary
Mean Intra-patient Change in Lund-Mackay CT Scan Score
Change in Lund-Mackay CT score for paired baseline and 24 week data. 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.
Time frame: Baseline and 24 weeks
Population: The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 111 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Device | Mean Intra-patient Change in Lund-Mackay CT Scan Score | -4.32 Scores on a scale | Standard Deviation 3.56 |
Primary
Mean Intra-patient Change in SNOT-20 Score
Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data. 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 and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the 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.
Time frame: Baseline and 24 weeks
Population: The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 113 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Device | Mean Intra-patient Change in SNOT-20 Score | -1.16 Scores on a scale | Standard Deviation 1.03 |
Secondary
Mean Number of Days to Return to Normal Activities
Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living
Time frame: 2 weeks
Population: Not all subjects were compliant with reporting the Number of Days to Return to Normal Activities post procedure. Data are available for 181 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Device | Mean Number of Days to Return to Normal Activities | 2.3 days | Standard Deviation 1.8 |
Secondary
Procedure Tolerability
Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.
Time frame: Day 0 (Day of Procedure)
Population: Not all subjects were compliant will filling out tolerability questionnaires. Data are available for 198 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Device | Procedure Tolerability | 163 number of participants |
Secondary
Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.
Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events.
Time frame: Day 0 (Day of Procedure)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Device | Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events. | 552 number of sinuses |
Secondary
Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary
Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary
Time frame: Day 0 (Day of Procedure)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Device | Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary | 552 number of sinuses |