Novapak Prospective Observational Clinical Trial

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.

• 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.

Primary outcomes

• 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 outcomes

• 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 - 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.
• 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 - 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 - 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.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

Participant flow

Outcome results

• Safety Assessment - Adverse Events Related to Device (Primary), Count of units, Adverse Events: Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined 0
• Safety Assessment - All Adverse Events (Primary), Number, Adverse Events: Novapak Subjects 62
• Effectiveness Assessment - Total Number of Adhesions at Day 14 and Day 30 Post Treatment (Secondary), Count of units, Sinuses: 14-Day Follow-up 6; 30-Day Follow-up 5
• Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment (Secondary), Count of units, Sinuses: 14-Day Follow-up 132; 30-Day Follow-up 127
• Effectiveness Assessment - Bleeding Control (Secondary), Count of units, Sinuses: Prior to Novapak Insertion 8; Post Novapak Insertion 86
• Effectiveness Assessment - Healing (Secondary), Mean, score on a scale: Pre-Surgery 3.27 +/- 1.95; 14-Day Follow-up 1.99 +/- 1.28; 30-Day Follow-up 1.09 +/- 1.26
• Effectiveness Assessment - Health Assessment (Secondary), Mean, score on a scale: Pre-Surgery 40.59 +/- 18.05; 14-Day Follow-up 25.03 +/- 18.83; 30-Day Follow-up 18.67 +/- 16.80

Adverse events

Time frame: Adverse events were collected from procedure through 30-day follow-up.

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2022-10-24)
• Statistical Analysis Plan (PDF, 2023-04-28)

• Karen R McKenzie, MS, Study director, Medtronic