XprESS Maxillary Balloon Dilation Study
Study Details
Study Description
Brief Summary
A prospective, single-arm, post approval pilot study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study is evaluating transnasal sinus balloon dilation without tissue removal to treat the maxillary sinuses in patients with sinusitis. The study will be assessing symptomatic improvement post procedure.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Balloon sinus dilation Balloon dilation of the maxillary sinus using a transnasal approach. |
Device: Balloon sinus dilation
Other Names:
|
Outcome Measures
Primary Outcome Measures
- SNOT-20 Score [Baseline and 6 months post procedure]
The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score.
Secondary Outcome Measures
- Recovery Time [1 week post procedure]
Patient-reported time from procedure to ability to return to normal daily activities.
- Procedural Pain Scores [Immediately post procedure]
Procedure pain/discomfort on a scale of 0 (no pain) to 10 (severe pain) as reported by the participant.
- Revision Rate [6 Months post procedure]
The number of participants who require revision sinus surgery during the study duration.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be at least 18 years of age.
-
Must have uncomplicated sinusitis of the maxillary sinuses with or without anterior ethmoid disease.
-
Meet EITHER the Anthem Coverage Guideline OR BlueCross BlueShield of North Carolina Corporate Medical Policy for medically necessary functional endoscopic sinus surgery (FESS) to treat uncomplicated sinusitis.
-
Have a CT scan within 6 months prior to enrollment.
-
Be mentally and physically capable (as per physician discretion) to participate in the investigation.
-
Be willing and able to sign the study-specific informed consent prior to any study-related procedures.
-
Be willing and able to undergo balloon dilation in the clinic setting.
Exclusion Criteria:
-
Have evidence of posterior ethmoid, sphenoid or frontal sinus (excludes presence of mucous retention cysts) disease requiring endoscopic sinus surgery or balloon dilatation.
-
Have presence of features consistent with sinus fungal disease.
-
Have evidence of gross polypoid disease within any of the sinuses or within the infundibulum.
-
Require concurrent nasal surgery (eg, septoplasty, turbinate reduction, etc).
-
Have previous sinus surgery (eg, sinus surgery or balloon sinuplasty).
-
Have nasal surgery (eg, septoplasty, turbinate reduction) performed within 3 months prior to enrollment.
-
Have any anatomical anomaly (ie, severe septal deviation) preventing transnasal access to the maxillary sinus outflow tract.
-
Have a history of primary ciliary dysfunction.
-
Have hemophilia.
-
Be currently undergoing, or have undergone in the past 6 months, chemotherapy for cancer or radiation therapy in the head or neck region.
-
Have a history of cystic fibrosis.
-
Have Sampter's Triad (ie, defined as having all 3 of the following: aspirin sensitivity, asthma, and sinonasal polyposis).
-
Have known sinonasal tumors or obstructive lesions.
-
Be pregnant at the time of enrollment.
-
Be unable to stop anticoagulant medication (eg, warfarin) until the International Normalized Ratio (INR) is below 1.5.
-
Be unable to stop antiplatelet (eg, clopidogrel, aspirin, etc.) for at least 7 days prior to study procedure.
-
Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Entellus Medical | Plymouth | Minnesota | United States | 55447 |
| 2 | Synergy ENT Specialists | Saint Louis | Missouri | United States | 63131 |
Sponsors and Collaborators
- Entellus Medical, Inc.
Investigators
- Principal Investigator: James D. Gould, MD, Synergy ENT Specialists
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2091-001
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Balloon Sinus Dilation |
|---|---|
| Arm/Group Description | Balloon dilation of the maxillary sinus using a transnasal approach. Balloon sinus dilation |
| Period Title: Overall Study | |
| STARTED | 21 |
| COMPLETED | 21 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Balloon Sinus Dilation |
|---|---|
| Arm/Group Description | Balloon dilation of the maxillary sinus using a transnasal approach. Balloon sinus dilation |
| Overall Participants | 21 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
52
(18)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
12
57.1%
|
| Male |
9
42.9%
|
| Region of Enrollment (participants) [Number] | |
| United States |
21
100%
|
| Lund-Mackay score (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
4.7
(3.4)
|
| Smoking status (Count of Participants) | |
| Nonsmokers |
19
90.5%
|
| Smokers |
2
9.5%
|
| Allergies (year-round or seasonal) (Count of Participants) | |
| Count of Participants [Participants] |
16
76.2%
|
Outcome Measures
| Title | SNOT-20 Score |
|---|---|
| Description | The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score. |
| Time Frame | Baseline and 6 months post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants with baseline and 6-month follow-up SNOT-20 assessments (matched pairs). |
| Arm/Group Title | Balloon Sinus Dilation |
|---|---|
| Arm/Group Description | Balloon dilation of the maxillary sinus using a transnasal approach. Balloon sinus dilation |
| Measure Participants | 21 |
| Baseline |
2.3
(0.8)
|
| 6-Month Follow-up |
0.8
(0.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Balloon Sinus Dilation |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P values <0.05 are considered statistically significant. | |
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Recovery Time |
|---|---|
| Description | Patient-reported time from procedure to ability to return to normal daily activities. |
| Time Frame | 1 week post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Balloon Sinus Dilation |
|---|---|
| Arm/Group Description | Balloon dilation of the maxillary sinus using a transnasal approach. Balloon sinus dilation |
| Measure Participants | 21 |
| Mean (Standard Deviation) [hours] |
16.1
(17.8)
|
| Title | Procedural Pain Scores |
|---|---|
| Description | Procedure pain/discomfort on a scale of 0 (no pain) to 10 (severe pain) as reported by the participant. |
| Time Frame | Immediately post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Balloon Sinus Dilation |
|---|---|
| Arm/Group Description | Balloon dilation of the maxillary sinus using a transnasal approach. Balloon sinus dilation |
| Measure Participants | 21 |
| Mean (Standard Deviation) [score on a scale] |
1.8
(1.8)
|
| Title | Revision Rate |
|---|---|
| Description | The number of participants who require revision sinus surgery during the study duration. |
| Time Frame | 6 Months post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Balloon Sinus Dilation |
|---|---|
| Arm/Group Description | Balloon dilation of the maxillary sinus using a transnasal approach. Balloon sinus dilation |
| Measure Participants | 21 |
| Count of Participants [Participants] |
0
0%
|
Adverse Events
| Time Frame | 6 months post procedure | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Balloon Sinus Dilation | |
| Arm/Group Description | Balloon dilation of the maxillary sinus using a transnasal approach. Balloon sinus dilation | |
All Cause Mortality |
||
| Balloon Sinus Dilation | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | |
Serious Adverse Events |
||
| Balloon Sinus Dilation | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/21 (4.8%) | |
| Endocrine disorders | ||
| Complication of diabetes mellitus | 1/21 (4.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Balloon Sinus Dilation | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Principal Clinical Research & Publications Manager |
|---|---|
| Organization | Stryker ENT |
| Phone | 764-463-1598 |
| ellen.omalley@stryker.com |
- 2091-001