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This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).
Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients.
One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XprESS Balloon Device | Other | Sinus dilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XprESS Balloon Device | Device | Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessments | Adverse event reporting as related to XprESS device or procedure | 1 month after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Sino-Nasal Outcome Test (SNOT-20) at 1 Month | The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sinuses Demonstrating Functional Patency | Functional patency of the sinus ostia originally treated with XprESS was assessed by the clinical site either by visual endoscopic evidence of a clear drainage path or radiographic evidence of a completely aerated sinus at 12-month follow-up for the first 50 patients treated in the study. | 12 months post procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Grebner | Entellus Medical | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Sinus Center | San Antonio | Texas | 78006 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23424023 | Result | Brodner D, Nachlas N, Mock P, Truitt T, Armstrong M, Pasha R, Jung C, Atkins J. Safety and outcomes following hybrid balloon and balloon-only procedures using a multifunction, multisinus balloon dilation tool. Int Forum Allergy Rhinol. 2013 Aug;3(8):652-8. doi: 10.1002/alr.21156. Epub 2013 Feb 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | XprESS Balloon Device | XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Procedure Safety (1-Month) |
|
| |||||||||||||||||||||
| Long-term Follow-up |
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | XprESS Balloon Device | XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety Assessments | Adverse event reporting as related to XprESS device or procedure | All enrolled participants. | Posted | Count of Participants | Participants | 1 month after procedure |
|
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Adverse events from time of procedure through 12 months post procedure. Per protocol, only 50 of the 175 enrolled participants were followed after the 1-month postprocedure visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | XprESS Balloon Device | XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Clinical Research & Publications Manager | Stryker ENT | 763-463-1598 | ellen.omalley@stryker.com |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| Baseline and 1 month after procedure |
| SNOT-20 at 6 Months | The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20. | Baseline and 6 months post procedure |
| SNOT-20 at 12 Months | The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20. | Baseline and 12 months post procedure |
| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lund-Mackay score | The Lund-Mackay score is a method to grade CT scan findings of the paranasal sinuses and ostiomeatal complex for chronic rhinosinusitis. Each sinus and ostiomeatal complex on each side is scored as 0 (no abnormality), 1 (partial opacification) or 2 (complete opacification). The ostiomeatal complex is assigned a score of either 0 (not obstructed) or 2 (obstructed). An aplastic frontal sinus is assigned a score of 0. The Lund-Mackay score can range from 0 to 24 with higher values indicating greater disease severity. | Lund-Mackay is provided for those participants who had a preoperative scan available. | Mean | Standard Deviation | units on a scale |
|
| SNOT-20 | The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20. | Baseline SNOT-20 assessments were inadvertently lost for 5 participants. | Mean | Standard Deviation | units on a scale |
|
| Nasal polyps | Number of participants with nasal polyps. | Count of Participants | Participants |
|
| Area of sinusitis | Number of participants with disease in the applicable sinus. | Count of Participants | Participants |
|
|
| Secondary | Sino-Nasal Outcome Test (SNOT-20) at 1 Month | The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20. | All participants with baseline and 1-month SNOT-20 scores. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 month after procedure |
|
|
|
|
| Secondary | SNOT-20 at 6 Months | The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20. | Participants enrolled in the long-term follow-up who have matching baseline and 6-month SNOT-20 scores. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months post procedure |
|
|
|
|
| Secondary | SNOT-20 at 12 Months | The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20. | Participants who were enrolled in the long-term follow-up and have matching baseline and 12-month SNOT-20 scores. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post procedure |
|
|
|
| Other Pre-specified | Number of Sinuses Demonstrating Functional Patency | Functional patency of the sinus ostia originally treated with XprESS was assessed by the clinical site either by visual endoscopic evidence of a clear drainage path or radiographic evidence of a completely aerated sinus at 12-month follow-up for the first 50 patients treated in the study. | Frontal and sphenoid sinuses treated with XprESS and evaluated by endoscopy or CT scan at 12 months post procedure. | Posted | Count of Units | Sinuses | 12 months post procedure | Sinuses | Sinuses |
|
|
|
| 0 |
| 175 |
| 0 |
| 175 |
| 0 |
| 175 |
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |