Novapak Prospective Observational Clinical Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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:
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Collecting all AEs directly attributed to the device and/or those that cannot be determined; and calculating a point estimate and confidence interval
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Novapak Subjects Subjects that are enrolled in the Novapak Study. |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Novapak Safety Assessment [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.
- Novapak Safety Assessment [30 days]
Outcome Measure #2 for the Primary Outcome is the total number of Adverse Events.
Secondary Outcome Measures
- Novapak Effectiveness Assessment [30 days]
Outcome Measure #3 for the Secondary Outcome Measures is number of adhesions from procedure through 1-month post treatment.
- Novapak Effectiveness Assessment [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) from procedure through 1-month post treatment.
- Novapak Effectiveness Assessment [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.
- Novapak Effectiveness Assessment [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.
- Novapak Effectiveness 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is at least 18 years of age.
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Subject undergoing nasal/sinus surgery with the intended need for nasal sinus packing (i.e., Novapak).
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After being informed of the nature of the study; the subject understands, agrees to its provisions, is willing to participate and provide written consent.
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Mentally stable and able to follow the instructions for self-assessment/questionnaire completion.
Exclusion Criteria:
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Subject has a shellfish allergy.
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Subject has known bleeding disorder or prescribed anticoagulants.
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Subject has craniofacial abnormalities that may interfere with access to the sinuses.
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Subject is immunocompromised (e.g., taking immunosuppressive medication).
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medtronic Surgical Technologies
Investigators
- Study Director: Karen R McKenzie, MS, Medtronic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDT 22031