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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novapak Subjects | Subjects that are enrolled in the Novapak Study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novapak Nasal Sinus Packing and Stent | Device | Potential subjects will have the need to undergo nasal/sinus surgery using a space-occupying stent and will perform daily self-saline nasal irrigations. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Safety Assessment - All Adverse Events | Outcome Measure #2 for the Primary Outcome is the total number of Adverse Events. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited from the practices and clinics of the participating Study Investigators or from other non-investigator Otolaryngologist or Rhinologist physician referrals. Potential subjects will have the need to undergo nasal/sinus surgery using a space-occupying stent.
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| Name | Affiliation | Role |
|---|---|---|
| Karen R McKenzie, MS | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ENT Associates of South Florida | Boca Raton | Florida | 33487 | United States | ||
| University of Miami |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
| |||||||||||||
| 14-Day Follow-up |
| |||||||||||||
| 30-Day Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 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. | Posted | Count of Units | Adverse Events | 30 days | Adverse Events | Adverse Events |
|
Adverse events were collected from procedure through 30-day follow-up.
All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
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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 | Novapak Subjects | 86 total subjects were enrolled in the Novapak Study with 0 reported deaths. 77 subjects were implanted with the Novapak device and underwent Adverse Event Assessment(s). 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Scar | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rianna Rapson - Clinical Study Manager | Medtronic | 763-526-2170 | rianna.k.rapson@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 24, 2022 | Apr 16, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2023 | Apr 16, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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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. |
| 30 days |
| 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. | 1 day |
| 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. | 30 day |
| 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. | 30 day |
| Miami |
| Florida |
| 33136 |
| United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| St. Joseph's Health Care | London | Onterio | N6A 4V2 | Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race was not collected for Canadian site. Only US sites were able to report race (n=57). | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Adverse Events |
|
|
| Primary | Safety Assessment - All Adverse Events | Outcome Measure #2 for the Primary Outcome is the total number of Adverse Events. | Posted | Number | Adverse Events | 30 days |
|
|
|
| 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. | This outcome was analyzed by sinus not by subject | Posted | Count of Units | Sinuses | 30 days | Sinuses | Sinuses |
|
|
|
| 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. | For this outcome, analysis was done by sinus not by subject | Posted | Count of Units | Sinuses | 30 days | Sinuses | 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. | For this outcome, analysis was done by sinus, not by subject | Posted | Count of Units | Sinuses | 1 day | Sinuses | 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. | For this outcome, analysis was done by sinus not by subject | Posted | Mean | Standard Deviation | score on a scale | 30 day | Sinuses | Sinuses |
|
|
|
| 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. | The analysis population is number of subjects that completed the SNOT-22 questionnaire at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | 30 day |
|
|
|
| 0 |
| 77 |
| 2 |
| 77 |
| 38 |
| 77 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Blindness unilateral | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| Facial discomfort | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hyperaesthesia teeth | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hyposmia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nasal crusting | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nasal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Paranasal sinus inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| Post procedural fever | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Sensory loss | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Sinusitis bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
PIs may publish as long as publications are provided to Medtronic for review at least 60 days prior to submission or presentation. Additionally, PIs will not independently publish, publicly disclose, present or discuss any Study results until a multi-center publication is released. If a multi-center publication is not released within one year after completion PIs will have the right to publish the results of and information pertaining to their activities on the Study.
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| BETWEEN 25 AND 50% OF MIDDLE TURBINATE HEIGHT |
|
| >50% OF MIDDLE TURBINATE HEIGHT |
|
| GRADE 2: SLIGHT BLEEDING - OCCASIONAL SUCTIONING REQUIRED |
|
| GRADE 3: SLIGHT BLEEDING - FREQUENT SUCTIONING REQUIRED; BLEEDING THREATENS SURGICAL FIELD A FEW ... |
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| GRADE 4: MODERATE BLEEDING - FREQUENT SUCTIONING REQUIRED AND BLEEDING THREATENS SURGICAL FIELD D... |
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| GRADE 5: SEVERE BLEEDING - CONSTANT SUCTIONING REQUIRED; BLEEDING APPEARS FASTER THAN CAN BE REMO... |
|