Nasal Airway Obstruction
Conditions
Brief summary
The Novapak study is a prospective, observational, multi-site, non-controlled, non-randomized, case-series, with a 2 week and 1-month follow-up in adults undergoing nasal/sinus surgery with Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively and is being conducted to obtain clinical data on the safety and effectiveness of the Novapak device under use as intended in the device indications.
Detailed description
The primary objective is to assess the safety of the Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively in patients undergoing nasal/sinus surgery by: * Collecting all AEs directly attributed to the device and/or those that cannot be determined; and calculating a point estimate and confidence interval * Collecting all AEs and calculating an overall rate and safety profile for the device The secondary objectives are to confirm device effectiveness through assessing adhesions, bleeding, healing and health during the procedure, 2 weeks and 1-month post treatment.
Interventions
DEVICENovapak Nasal Sinus Packing and Stent
Potential subjects will have the need to undergo nasal/sinus surgery using a space-occupying stent and will perform daily self-saline nasal irrigations.
Sponsors
Medtronic Surgical Technologies
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject is at least 18 years of age. 2. Subject undergoing nasal/sinus surgery with the intended need for nasal sinus packing (i.e., Novapak). 3. After being informed of the nature of the study; the subject understands, agrees to its provisions, is willing to participate and provide written consent. 4. Mentally stable and able to follow the instructions for self-assessment/questionnaire completion.
Exclusion criteria
1. Subject has a shellfish allergy. 2. Subject has known bleeding disorder or prescribed anticoagulants. 3. Subject has craniofacial abnormalities that may interfere with access to the sinuses. 4. Subject is immunocompromised (e.g., taking immunosuppressive medication). 5. Subject is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment - Adverse Events Related to Device | 30 days | Outcome Measure #1 for the Primary Outcome is the total number of Adverse Events that are directly attributed to the device and/or those that cannot be determined. |
| Safety Assessment - All Adverse Events | 30 days | Outcome Measure #2 for the Primary Outcome is the total number of Adverse Events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness Assessment - Bleeding Control | 1 day | Outcome Measure #5 for the Secondary Outcome Measures is to measure control of bleeding by comparing Boezaart Surgical Field Grading Scale scores post operatively, prior to Novapak insertion and post Novapak insertion. The Boezaart scale grades bleeding from Grade 0: No Bleeding through Grade 5: Severe Bleeding. |
| Effectiveness Assessment - Total Number of Adhesions at Day 14 and Day 30 Post Treatment | 30 days | Outcome Measure #3 for the Secondary Outcome Measures is number of adhesions observed by endoscopic examination from procedure through 1-month post treatment. |
| Effectiveness Assessment - Health Assessment | 30 day | Outcome Measure #7 for the Secondary Outcome Measures is to measure health by comparing subject scores from the SNOT-22 questionnaire before surgery and at 2 weeks and 1-month post treatment. The Sino-Nasal Outcome Test (SNOT-22) is a validated questionnaire used to assess the severity of 22 symptoms related to the nasal sinuses using a 0-5-point scale (0 = No problem; 1 = Very mild problem; 2 = Mild or slight problem; 4 = Moderate problem; 5 = Problem as bad as it can be). Minimum score: 0; Maximum score: 110. The higher the score the worse the problems are. |
| Effectiveness Assessment - Healing | 30 day | Outcome Measure #6 for the Secondary Outcome Measures is to measure healing by comparing Lund-Kennedy scores before surgery and at 2 weeks and 1-month post treatment. The Lund-Kennedy Scoring minimum is 0 and maximum is 10, with higher scores indicating worse observed disease. The Lund-Kennedy grading system is as follows: Nasal Polyps 0 = none; 1 = confined to middle meatus; 2 = beyond middle meatus Discharge 0 = none; 1 = clear and thin; 2 = thick and purulent Edema 0 = absent; 1 = mild; 2 = severe Scarring 0 = absent; 1 = mild; 2 = severe Crusting 0 = absent; 1 = mild; 2 = severe Numerical values for each term are summed for each sinus analyzed; and mean averages are reported. |
| Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment | 30 days | Outcome Measure #4 for the Secondary Outcome Measures is the graded percentage of vertical height of the middle turbinate taken up by the adhesion using an ordinal scale (0-3), where '0' is No Adhesion Present, and '3' is \>50% of middle turbinate height. This scoring is the Valentine method, and participants are graded based on their endoscopic examination. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Novapak Subjects Subjects that are enrolled in the Novapak Study.
Novapak Nasal Sinus Packing and Stent: Potential subjects will have the need to undergo nasal/sinus surgery using a space-occupying stent and will perform daily self-saline nasal irrigations. | 86 |
| Total | 86 |
Baseline characteristics
| Characteristic | Novapak Subjects |
|---|---|
| Age, Continuous | 48.62 years STANDARD_DEVIATION 17.36 |
| Race/Ethnicity, Customized RACE AFRICAN AMERICAN | 1 Participants |
| Race/Ethnicity, Customized RACE ARAB | 1 Participants |
| Race/Ethnicity, Customized RACE ASIAN | 1 Participants |
| Race/Ethnicity, Customized RACE ASIAN INDIAN | 1 Participants |
| Race/Ethnicity, Customized RACE BAHAMIAN | 1 Participants |
| Race/Ethnicity, Customized RACE BLACK OR AFRICAN AMERICAN | 1 Participants |
| Race/Ethnicity, Customized RACE LATIN AMERICAN | 4 Participants |
| Race/Ethnicity, Customized RACE MEDITERRANEAN | 1 Participants |
| Race/Ethnicity, Customized RACE MIDDLE EASTERN | 1 Participants |
| Race/Ethnicity, Customized RACE NOT REPORTED | 2 Participants |
| Race/Ethnicity, Customized RACE OTHER | 1 Participants |
| Race/Ethnicity, Customized RACE WHITE | 40 Participants |
| Race/Ethnicity, Customized RACE WHITE CARIBBEAN | 2 Participants |
| Region of Enrollment Canada | 29 participants |
| Region of Enrollment United States | 57 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 77 |
| other Total, other adverse events | 38 / 77 |
| serious Total, serious adverse events | 2 / 77 |
Outcome results
Primary
Safety Assessment - Adverse Events Related to Device
Outcome Measure #1 for the Primary Outcome is the total number of Adverse Events that are directly attributed to the device and/or those that cannot be determined.
Time frame: 30 days
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Safety Assessment - Adverse Events Related to Device | Device Relatedness - Causal Relationship | 0 Adverse Events |
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Safety Assessment - Adverse Events Related to Device | Device Relatedness - Probable | 1 Adverse Events |
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Safety Assessment - Adverse Events Related to Device | Device Relatedness - Possible | 2 Adverse Events |
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Safety Assessment - Adverse Events Related to Device | Device Relatedness - Not Related | 59 Adverse Events |
Primary
Safety Assessment - All Adverse Events
Outcome Measure #2 for the Primary Outcome is the total number of Adverse Events.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Safety Assessment - All Adverse Events | 62 Adverse Events |
Secondary
Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment
Outcome Measure #4 for the Secondary Outcome Measures is the graded percentage of vertical height of the middle turbinate taken up by the adhesion using an ordinal scale (0-3), where '0' is No Adhesion Present, and '3' is \>50% of middle turbinate height. This scoring is the Valentine method, and participants are graded based on their endoscopic examination.
Time frame: 30 days
Population: For this outcome, analysis was done by sinus not by subject
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment | NO ADHESION PRESENT | 132 Sinuses |
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment | BETWEEN 25 AND 50% OF MIDDLE TURBINATE HEIGHT | 0 Sinuses |
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment | >50% OF MIDDLE TURBINATE HEIGHT | 1 Sinuses |
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment | < 25% OF MIDDLE TURBINATE HEIGHT | 5 Sinuses |
| 30-Day Follow-up | Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment | >50% OF MIDDLE TURBINATE HEIGHT | 0 Sinuses |
| 30-Day Follow-up | Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment | NO ADHESION PRESENT | 127 Sinuses |
| 30-Day Follow-up | Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment | < 25% OF MIDDLE TURBINATE HEIGHT | 4 Sinuses |
| 30-Day Follow-up | Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment | BETWEEN 25 AND 50% OF MIDDLE TURBINATE HEIGHT | 1 Sinuses |
Secondary
Effectiveness Assessment - Bleeding Control
Outcome Measure #5 for the Secondary Outcome Measures is to measure control of bleeding by comparing Boezaart Surgical Field Grading Scale scores post operatively, prior to Novapak insertion and post Novapak insertion. The Boezaart scale grades bleeding from Grade 0: No Bleeding through Grade 5: Severe Bleeding.
Time frame: 1 day
Population: For this outcome, analysis was done by sinus, not by subject
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Effectiveness Assessment - Bleeding Control | GRADE 1: SLIGHT BLEEDING - NO SUCTIONING REQUIRED | 76 Sinuses |
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Effectiveness Assessment - Bleeding Control | GRADE 0: NO BLEEDING (CADAVERIC CONDITIONS) | 8 Sinuses |
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Effectiveness Assessment - Bleeding Control | GRADE 2: SLIGHT BLEEDING - OCCASIONAL SUCTIONING REQUIRED | 29 Sinuses |
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Effectiveness Assessment - Bleeding Control | GRADE 3: SLIGHT BLEEDING - FREQUENT SUCTIONING REQUIRED; BLEEDING THREATENS SURGICAL FIELD A FEW ... | 23 Sinuses |
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Effectiveness Assessment - Bleeding Control | GRADE 4: MODERATE BLEEDING - FREQUENT SUCTIONING REQUIRED AND BLEEDING THREATENS SURGICAL FIELD D... | 3 Sinuses |
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Effectiveness Assessment - Bleeding Control | GRADE 5: SEVERE BLEEDING - CONSTANT SUCTIONING REQUIRED; BLEEDING APPEARS FASTER THAN CAN BE REMO... | 0 Sinuses |
| 30-Day Follow-up | Effectiveness Assessment - Bleeding Control | GRADE 4: MODERATE BLEEDING - FREQUENT SUCTIONING REQUIRED AND BLEEDING THREATENS SURGICAL FIELD D... | 0 Sinuses |
| 30-Day Follow-up | Effectiveness Assessment - Bleeding Control | GRADE 3: SLIGHT BLEEDING - FREQUENT SUCTIONING REQUIRED; BLEEDING THREATENS SURGICAL FIELD A FEW ... | 0 Sinuses |
| 30-Day Follow-up | Effectiveness Assessment - Bleeding Control | GRADE 0: NO BLEEDING (CADAVERIC CONDITIONS) | 86 Sinuses |
| 30-Day Follow-up | Effectiveness Assessment - Bleeding Control | GRADE 1: SLIGHT BLEEDING - NO SUCTIONING REQUIRED | 53 Sinuses |
| 30-Day Follow-up | Effectiveness Assessment - Bleeding Control | GRADE 5: SEVERE BLEEDING - CONSTANT SUCTIONING REQUIRED; BLEEDING APPEARS FASTER THAN CAN BE REMO... | 0 Sinuses |
| 30-Day Follow-up | Effectiveness Assessment - Bleeding Control | GRADE 2: SLIGHT BLEEDING - OCCASIONAL SUCTIONING REQUIRED | 0 Sinuses |
Secondary
Effectiveness Assessment - Healing
Outcome Measure #6 for the Secondary Outcome Measures is to measure healing by comparing Lund-Kennedy scores before surgery and at 2 weeks and 1-month post treatment. The Lund-Kennedy Scoring minimum is 0 and maximum is 10, with higher scores indicating worse observed disease. The Lund-Kennedy grading system is as follows: Nasal Polyps 0 = none; 1 = confined to middle meatus; 2 = beyond middle meatus Discharge 0 = none; 1 = clear and thin; 2 = thick and purulent Edema 0 = absent; 1 = mild; 2 = severe Scarring 0 = absent; 1 = mild; 2 = severe Crusting 0 = absent; 1 = mild; 2 = severe Numerical values for each term are summed for each sinus analyzed; and mean averages are reported.
Time frame: 30 day
Population: For this outcome, analysis was done by sinus not by subject
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Effectiveness Assessment - Healing | 3.27 score on a scale | Standard Deviation 1.95 |
| 30-Day Follow-up | Effectiveness Assessment - Healing | 1.99 score on a scale | Standard Deviation 1.28 |
| 30-Day Follow-up | Effectiveness Assessment - Healing | 1.09 score on a scale | Standard Deviation 1.26 |
Secondary
Effectiveness Assessment - Health Assessment
Outcome Measure #7 for the Secondary Outcome Measures is to measure health by comparing subject scores from the SNOT-22 questionnaire before surgery and at 2 weeks and 1-month post treatment. The Sino-Nasal Outcome Test (SNOT-22) is a validated questionnaire used to assess the severity of 22 symptoms related to the nasal sinuses using a 0-5-point scale (0 = No problem; 1 = Very mild problem; 2 = Mild or slight problem; 4 = Moderate problem; 5 = Problem as bad as it can be). Minimum score: 0; Maximum score: 110. The higher the score the worse the problems are.
Time frame: 30 day
Population: The analysis population is number of subjects that completed the SNOT-22 questionnaire at each timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Effectiveness Assessment - Health Assessment | 40.59 score on a scale | Standard Deviation 18.05 |
| 30-Day Follow-up | Effectiveness Assessment - Health Assessment | 25.03 score on a scale | Standard Deviation 18.83 |
| 30-Day Follow-up | Effectiveness Assessment - Health Assessment | 18.67 score on a scale | Standard Deviation 16.8 |
Secondary
Effectiveness Assessment - Total Number of Adhesions at Day 14 and Day 30 Post Treatment
Outcome Measure #3 for the Secondary Outcome Measures is number of adhesions observed by endoscopic examination from procedure through 1-month post treatment.
Time frame: 30 days
Population: This outcome was analyzed by sinus not by subject
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined | Effectiveness Assessment - Total Number of Adhesions at Day 14 and Day 30 Post Treatment | 6 Sinuses |
| 30-Day Follow-up | Effectiveness Assessment - Total Number of Adhesions at Day 14 and Day 30 Post Treatment | 5 Sinuses |